Model Number(s): PB840 Ventilator (4-840120DIUU-XX). The product is a component of the Puritan Bennett 840 Ventilator: T

FDA device recall Z-1809-2014 · posted 2014-06-17 · Terminated

Recall details

Recalling firm

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.

Action taken

Covidien will be issuing the Product Notification letter in 2014. Customers are requested to forward the letter to anyone they may have transferred or assigned for use one of the 9.4display configuration ventilators. Service engineers will be replacing the BLI PCBA with a new design containing the 1.0 ampere fuse and then destroying the old PCBA. Ventilators replaced with newer models under the commercial program will be returned to Covidien for disposal. Should you have any questions regarding this letter or to report any issues with the Puritan Bennett" 840 ventilator contact our Technical Support Department at 1-800-255-6774, option 4, then option 1, to ensure proper device reporting procedures are followed. Thank you for your prompt attention to this matter.

Root cause

Component design/selection

Status

Terminated

Product code

CBK

Quantity affected

7371

Distribution

Worldwide Distribution - USA (nationwide) including the states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH,

Date initiated

2014-06-04

Date posted

2014-06-17

Date terminated

2016-07-11

Location

Boulder, CO

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