Recall Z-1809-2014— Nellcor Puritan Bennett Inc. (dba Covidien LP)

Name: FDA recall Z-1809-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-04

Class II · Terminated

Class II FDA medical device recall by Nellcor Puritan Bennett Inc. (dba Covidien LP), initiated 2014-06-04, terminated 2016-07-11. It names one FDA 510(k) clearance: K970460. Product: 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. Reason: 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..

Recalling firm: Nellcor Puritan Bennett Inc. (dba Covidien LP)
Classification: Class II
Status: Terminated
Initiated: 2014-06-04
Terminated: 2016-07-11
Firm location: Boulder, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K970460 — NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)Puritan Bennett Corp.·cleared 1998-04-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.