Puritan Bennett 980 Series Ventilator -Ventilator (2018-09-20)

Starting date:

September 20, 2018

Posting date:

November 2, 2018

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-68158

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  Reason
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  Affected products

Affected products

Puritan Bennett 980 Series Ventilator - Ventilator

Reason

Medtronic is issuing a Software update (Maintenance Release MR 5.4) to enhance the functionality of PB980 ventilators and correct the concerns raised by TGA (Australia's Therapeutic Goods Administration. The concerns raised by TGA surround External USB Drive performance and its impact on Graphic User Interface (GUI) functionality and labeling of the scalar waveform displayed on GUI during ventilation.

Affected products