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Puritan Bennett 980 Series Ventilator (2015-01-16)
- Starting date:
- January 16, 2015
- Posting date:
- January 30, 2015
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-43499
Recalled Products
Puritan Bennett 980 Series Ventilator
Reason
During a GUI transient reset, the primary display becomes blank for approximately 30 seconds. It is important to note that the ventilator continues to provide full respiratory support. During that short period, high-priority audio and visual alarms are activated, and the secondary status display provides the operator key ventilator status data and states "display failed", "ventilating as set" and "replace ventilator". After the reset cycle completes, the GUI display refreshes, the alarms are terminated and the ventilator continues full operation.
Affected products
Puritan Bennett 980 Series Ventilator
Lot or serial number
All serial numbers.
Model or catalog number
- 980S1ENDICU
- 980U1ENDICU
Companies
- Manufacturer
-
Covidien LLC
15 Hampshire Street
Mansfield
02048
Massachusetts
UNITED STATES