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Puritan bennett 980 series ventilator
Official notice
29 Nov 2021
Last checked
29 Nov 2021
An official Health Canada notice concerns Puritan bennett 980 series ventilator. 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 Published 2021-11-29.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63661
Official notice
2021-11-29
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Covidien, Puritan Bennett 980 Series Ventilator.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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