Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized Uptake Value (SUV) within MIM Software versions 7.2.0 through 7.2.6.could result.
The machine side connector of the filter HME may be occluded by plastic which prevents proper airflow. The issue may lead to ventilation bag malfunction in which the user is unable to inflate/deflate properly during manual ventilation. Potential risks to health include oxygen deprivation, leading to respiratory distress and medical complications.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death. During a delivery accuracy dry run testing of the 780G NGP infusion pump under dynamic pressure conditions, the firm observed that when air pressure decreased during take-off simulation, on average 0.569U more insulin was delivered in 15 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate; when air pressure increased during landing simulation, on average 0.537 U less insulin was delivered in 25 minutes than the expected delivery volume at ambient pressure at 1 U/hr delivery rate. The firm also observed that the mechanisms causing the variations in delivery volumes are independent of the delivery rate.
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version
Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation (fish-mouthing/braid narrowing/braid collapse) noted during procedure and post-procedure, typically noted at 6-12 month imaging follow-up, potentially can lead to thrombosis and/or serious adverse events. Higher risk in females less-than-or-equal-to 45 years of age
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version
Patient chart stickers provided inside the packaging may incorrectly identify ET Rigid Abutments as Regular version whereas the actual product is a Mini version; and identify the ET Multi Abutments as Mini version whereas the actual product is a Regular version
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
Telcare, LLC has received customer complaints related to battery expansion/swelling for its Philips Connected Blood Glucose Meter (i.e., BGM 4 brand name) Monitoring System.. The issue was identified by post market surveillance data (customer complaints) - events of battery expansion/swelling and associated symptoms, e.g., leading to the device's removable back cover (battery port) to separate. If there is a loss of primary function of the device due to the described device defect, an immediate health consequence that may result is prolonged hypoglycemia or hyperglycemia due to delay in treatment, as the blood glucose measurement is not available to guide treatment. In a worst-case situation, there is potential for battery swelling to result in explosion of the battery and/ or device. Exposure to explosion, and subsequently projectiles from the explosion, may result in several immediate health consequences, including concussion, headache, dizziness, eye irritation, blurred vision, eye injury, and vision impairment.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin delivery due to changes in air pressure, which can be found during airplane take-off or landing. An unexpected additional dose of insulin, which can occur during take-off, can result in severe hypoglycemia, altered mental status, seizure, coma, or death. An unexpected under-delivery of insulin, which can occur during landing, can result in severe hyperglycemia, dehydration, diabetic ketoacidosis, or death.
The initial current in certain chargers may lead to overheating and damage to the power resistors on the Alternating Current (AC) controller during the power-on sequence of the laser system, resulting in the laser system to not power on.