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Type of Product Medical Device
TGA Recall Reference RC-2017-RN-01429-1
Product Name/Description Rechargeable Li-Ion Batteries with incorrect firmware used in Puritan Bennett 980 Ventilators

Product Code: 10086042

Serial Numbers beginning with 1201xxxxx through 1712xxxxxx

ARTG Number: 221452
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 22/11/2017
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic has identified specific units of Lithium Ion batteries which are used in Puritan Bennett 980 ventilators, following reports that the batteries may not fully charge after installation. The scope of this notice includes batteries that were manufactured between December 2013 and May 2017, with serial numbers begin with 1201xxxxxx through 1712xxxxxx

A functional battery installed in the PB980 ventilator automatically recharges when the battery depletes and the ventilator is connected to AC power. In the case of a battery with incorrect firmware, it may fail to fully charge. This situation does not impact the ventilator’s operation when it is connected to AC power. However, if the ventilator is operated on battery power alone, this situation could limit the amount of time the ventilator is operational.
Recall Action Recall for Product Correction
Recall Action Instructions Notify all care environments in which the PB980 ventilators are used about this notification.
If PB980 ventilators have been distributed to other persons or facilities, promptly forward a copy of this letter to them.
Complete the attached form and return it as directed to confirm your receipt and understanding of this information.
Medtronic service engineers will inspect batteries in the field during scheduled or preventive maintenance. Batteries found to have the incorrect firmware will be replaced.
The PB980 ventilator may continue to be used as described in the Operator’s Manual.

This action has been closed out on 28/10/2019
Contact Information 1800 336 693 - Technical Service Department