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Puritan Bennett 980 Series Ventilator (2014-10-06)

Starting date:
October 6, 2014
Posting date:
October 14, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-41777

Recalled Products   

Puritan Bennett 980 Series Ventilator 

Reason

There are 2 issues:

  1. related to a capacitor failure in the backlight inverter printed circuit board assembly (PCBA) in the ventilator display that can cause a dimming of the display that may be accompanied by a burning ODO^.
  2. software related and can lead to a "ventilator inoperative" condition when the ventilator should resume ventilation.

Affected products

Puritan Bennett 980 Series Ventilator 

Lot or serial number

Not applicable  

Model or catalog number

980S1ENDICU
980U1ENDICU

Companies
Manufacturer
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES