Reported Jun 25, 2014 · Terminated
Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator:…
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nellcor Puritan Bennett Inc. (dba Covidien LP) · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214
Is this the product you have?
- Model Number(s)PB840 Ventilator (4-840120DIUU-XX). The product is a component
- of the Puritan Bennett 840 VentilatorThe 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
- Lot codes and dates
- 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,
- Amount recalled
- 7371
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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