The Recall Desk
HighFDA (Devices)·Z-1809-2014·Announced 2014-06-25

Nellcor Puritan Bennett PB840 Ventilator Display Component Recalled

Nellcor Puritan Bennett Inc. is recalling Backlight Inverter Printed Circuit Boards for PB840 Ventilators due to a potential loss of the graphical user interface display.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk medical device (ventilator) where a component failure requires moving a patient to another ventilator, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Nellcor Puritan Bennett Inc. (dba Covidien LP) is recalling the Backlight Inverter Printed Circuit Board (BLI PCBA) for the 9.4-inch display of the Puritan Bennett 840 (PB840) Ventilator. The affected component is 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 in hospitals and healthcare facilities.

The recall is due to a potential failure of the BLI PCBA, which can result in a loss of the graphical user interface (GUI) display. In the event of this failure, the ventilator continues to provide uninterrupted ventilatory support at the programmed settings for the patient. However, the loss of the display necessitates moving the patient to another ventilator.

The recall covers 7,371 units distributed worldwide, including the United States (nationwide), Canada, and Japan. Affected units are identified by display part number 4-079056-00 and serial numbers 4200000001 to 3510012377. Specific lots include 1032H, 1041H, 1042H, 1043H, 1008J, 1009J, 1010J, 1018K, 1019K, 1020K, 1021K, 1022K, 1023K, 1030L, 1031L, 1032L, 1033L, 1034L, and 1035L. Healthcare facilities should contact the manufacturer for further instructions.

The recalled product

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 in
Manufacturer
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Category
Medical Device — Ventilator
Hazard
Affected units
7,371

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

Related recalls

Same manufacturer · Nellcor Puritan Bennett Inc. (dba Covidien LP)

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Same hazard · display failure

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