Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities
Class I - DangerousWhat Should You Do?
- Check if you have this product: Display part number 4-079056-00; serial number 4200000001 to 3510012377 that have a 9.4 display. Lots 1032H,1041H,1042H,1043H,1008J,1009J,1010J,1018K,1019K,1020K,1021K,1022K,1023K,1030L,1031L,1032L,1033L,1034L,1035L,
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Nellcor Puritan Bennett Inc. (dba Covidien LP)
- Reason for Recall:
- In the case of a loss of GUI display due to a Backlight Inverter PCBA failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, there is a loss of display and thus there is a necessity to move the patient to another ventilator.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: The Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4 Display part number 4-079056-00. The PB840 Ventilator System is intended to provide invasive or non-invasive ventilator support and monitoring for infant, pediatric, and adult patients with respiratory failure or respiratory insufficiency. It is used in hospitals and healthcare facilities
Product Codes/Lot Numbers:
Display part number 4-079056-00; serial number 4200000001 to 3510012377 that have a 9.4 display. Lots 1032H,1041H,1042H,1043H,1008J,1009J,1010J,1018K,1019K,1020K,1021K,1022K,1023K,1030L,1031L,1032L,1033L,1034L,1035L,
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1809-2014
Related Recalls
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Nellcor Puritan Bennett Inc. (dba Covidien LP)
A software issue may lead to ventilator inoperative situations.
Covidien is conducting a field correction of the Vital Sync Virtual Patient Monitoring Platform and Informatics Manager due to a mismatch between the alarm priority on the medical devices and the Vital Sync system.