Health product recall

Puritan Bennett 980 Series Ventilator

Brand(s)
Last updated

Summary

Product
Puritan Bennett 980 Series Ventilator
Issue
Medical devices » Manufacturing defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

Puritan Bennett 980 Series Ventilator

More than 10 numbers, contact manufacturer.

980S1ENDICU

980S3ENDICU

980U1ENDICU

Issue

This voluntary medical device correction is being taken following the investigation of six customer reports stating that a total of four ventilators became inoperable during use. One of these reports indicated that, following the ventilator becoming inoperable while providing mechanical ventilation, the patient experienced cardio-respiratory complication, and passed away three days later. The investigation identified the root cause for these reports to be a manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly. Only the affected serial numbers are impacted by this medical device correction.

 

Recall start date: 2021-11-09

Additional information

Details
Original published date: 2021-12-01
Alert / recall type
Health product recall
Category
Health product » Medical device » Anaesthesiology
Companies

COVIDIEN LLC, 15 HAMPSHIRE STREET, MANSFIELD

MASSACHUSETTS, UNITED STATES

02048

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type I
Identification number
RA-63661