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Terminated

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

FDA Recall Z-1809-2014 · Posted 2014-06-17

Recall StatusTerminated
Product CodeCBK
Date Initiated2014-06-04
Date Terminated2016-07-11
Product Quantity7371

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.

Firm Action

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

Distribution Pattern

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, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and District of Columbia., and the countries of Canada and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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