Health product recall

Puritan Bennett 560 Ventilator

Brand(s)
Last updated

Summary

Product
Puritan Bennett 560 Ventilator
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products Lot or serial number Model or catalog number
Puritan Bennett 560 Ventilator More than 10 numbers, contact manufacturer. 4096600

Issue

Medtronic is issuing a voluntary medical device correction related to specific serial numbers of the turbine component of Puritan Bennett 500 series ventilators. This voluntary medical device correction is being issued following confirmation of six reports from customers where it was stated that the ventilator low pressure alarm annunciated, and the high priority indicator illuminated indicating a loss of gas supply resulting in the ventilator becoming inoperable.

In the event of a loss of gas supply resulting in an inoperable ventilator, the audible and visual alarms will alert a caregiver that an alternate form of ventilation is required. Loss of ventilation can lead to a delay of treatment, potentially resulting in hypoxia, dyspnea, or death. In the event the ventilator becomes inoperable, the patient should be transferred to another form of ventilation.

Medtronic is advising that continued use of pb500 ventilators is appropriate when the actions listed in the recall notification are taken into consideration unless this continued use is inconsistent with facility's internal policies and procedures.

Recall start date: August 23, 2022

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Anaesthesiology
Companies

Covidien LLC

15 Hampshire Street, Mansfield, Massachusetts, United States, 02048

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Identification number
RA-64517

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