Drager V Series Ventilator with the Optional PS500 External Power Supply Unit installed 의 리콜

Recall

RC-2017-RN-00176-1

Class I

2017-02-06

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00176-1

Dräger became aware that the battery capacity of the optional ps500 power supply unit was unexpectedly reduced. this resulted in batteries prematurely discharging, even though an adequate battery charge status was displayed. the "battery discharged" alarm was not in all cases triggered five minutes prior to battery discharge, as specified. when the batteries were completely discharged, the devices triggered the existing power failure alarm correctly. the reported issue may cause unexpected loss of automatic ventilation functionality.Further to the recall for product correction in feb 2016 (tga ref.: rc-2016-rn-00154-1), dräger has now developed device modifications to rectify the issue.

The device modifications include the following:  - Installation of a new software 2.50 with improved battery charge management  - Improved charge management for external batteries  - Option of performing a battery check to determine the battery's current runtime  - Option of displaying the remaining battery capacity in minutes  - Installation of an additional internal backup battery  - Replacement of the power supply unit to support both the external battery and an additional internal battery  - Replacement of the existing external batteries. The installation of a backup battery will ensure that the internal battery will continue to supply power should the external battery fail. Users are advised to continue to observe the information in the Feb 2016 letter until the devices have been updated with the improved system.