Events

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

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Laerdal Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01529-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-11-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01529-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    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.
  • Action
    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.

Device

Laerdal Compact Suction Unit 4 (LCSU 4) (portable suction unit intended for field and transport use)
  • Model / Serial
    Laerdal Compact Suction Unit 4 (LCSU 4) (portable suction unit intended for field and transport use)LCSU 4, 300ml Complete unitItem Number: 88006140LCSU 4, 800ml Complete unitItem Number: 88005140 Units manufactured from 1 May 2015 to 28 October 2016 that do not have 'RW' on labelARTG Number: 205931
  • Manufacturer
    Laerdal Pty Ltd

Manufacturer

Laerdal Pty Ltd