BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABINA

    MDR report key: 1946034 · Received December 17, 2010

    Report

    Report Number
    8030916-2010-00037
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    March 29, 2009
    Report Date
    March 30, 2009
    Manufacturer
    LIKO AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS PART OF A RETROSPECTIVE REVIEW IN ACCORDANCE WITH CAPA ACTIVITIES.

    Description of Event or Problem · 1

    HOME OWNER/USER REPORTED THAT SHE HAD PICKED UP HER MOTHER IN THE SAFETY VEST TO RETURN HER TO BED. PT'S HEAD WAS UP HIGH IN THE SLING DUE TO COPD. USER PUSHED THE LIFT FROM COMMODE TO THE BED AND USED THE CONTROL TO LOWER PT BUT IT WOULD NOT WORK. SHE COULD NOT USE/WORK THE EMERGENCY LOWERING, SO SHE TRIED A COMBINATION OF THINGS TO MAKE THE LIFT WORK AND NOTHING WOULD BRING HER DOWN. PT WAS IN DISTRESS, SO THEY CUT THE LOOPS OF THE VEST TO LET HER DOWN ONTO THE BED. NO INJURY WAS REPORTED. IT WAS LATER DISCOVERED THAT USER HAD ACCIDENTALLY PUSHED IN THE EMERGENCY BUTTON, WHICH CAUSED THE LIFT NOT TO OPERATE. LIFT IS BACK IN SERVICE AND WORKING AS DESIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABINA NON-AC POWERED PATIENT LIFT FSA LIKO AB SABINA II EE

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR