Laerdal Compact Suction Unit 4 (LCSU 4) (portable suction unit intended for field and transport use) 의 리콜

Recall

RC-2016-RN-01529-1

Class II

2016-11-24

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01529-1

Laerdal medical has become aware of a problem related to the on/off functionality of the lcsu 4. the on/off functionality is controlled by electronic components and one of these components might be damaged. the damage occurs over time when the unit is connected to a power source (battery or external power source), but is not related to frequency of use. a damaged component will result in failure of the on/off functionality whereby the lcsu 4 cannot be turned off, and it may turn on by itself. the unit can be turned off by removing the battery or the external power source.

Laedral will be providing replacement units. In the interim, Laedral is advising users to perform a test to identify if their unit has failing On/Off functionality, by turning the unit on then turning it off again. If the unit cannot be turned off using the On/Off button, the unit contains a damaged component and the device should be taken out of service. If the unit passes the test, the device can continue to be used until the replacement unit is received, but the following extra safety measures should be implemented: - Store the LCSU 4 unit without the battery connected. - Perform routine checks of the On/Off functionality by turning the unit on and off using the On/Off button. If the On/Off functionality fails during clinical use, the unit can continue to be used so long as it has power. The unit can be turned off by removing the battery or the external power source.