Other Medical Devices

Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized label removed and an unauthorized label applied, could lead to expired Defibtech AED Pads appearing as though they are within the acceptable shelf life. There is a possibility of hydrogel drying, which may result in poor electrical connection to the patient, which can reduce the energy delivered to the patient.

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

The DNA fragments for this specific lot number are too large, resulting in potential background around the cells due to suboptimal hybridization. An absence of signal could also be observed as a result of the suboptimal hybridization of the larger DNA fragments. The user may interpret potential background as a false positive result and an absence of signal as a false negative result, if proper positive and negative controls are not included.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

There have been cases of failure of the main board due to condensation water drained from the Peltier dehumidifier, leaked out from the tray, resulting in a short circuit. In the serious case, the main board and adjacent cables are partly charred. In the minor case, the Y motor and its surrounding die cast part become rusty. These failures could result in delay in patient sample testing.

Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.

There has been an increase in the number of complaints related to the separation of the female connector from the main body of the transfer set.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.

Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions remain operational before reset, control maintained through backup control panel, but second reset may occur, may lead to gas blender standby, then gas blender must be reactivated using user interface on blender, sensors deactivated until new case started; GUI reset can lead to Hypoxia and Hypoperfusion.

Potential safety issue where a patient may be harmed while preparing for or during a scan.

Deviations in the manufacturing process created a compromise in the sterile barrier, in which sterility cannot be assured during the duration of the product's 2-year shelf life.