BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RISEATLAS

    MDR report key: 7919876 · Received September 28, 2018

    Report

    Report Number
    3009481053-2018-00041
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    September 4, 2018
    Report Date
    November 9, 2018
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL INVESTIGATION SHOWS THAT LOCTITE ON BELL SPRING OF COMPONENT WHICH ENABLES ATTACHMENT OF SLING BAR TO CEILING LIFT HAD WORN DOWN, CAUSING THA BELL SPRING TO PARTIALLY RETRACT INTO THE COMPONENT. THE BELL SPRINGS PURPOSE IS TO MINIMIZE RISK FOR SLING BAR DETACHMENT. PARTIAL RETRACTION OF BELL SPRING WOULD REDUCE ITS INTENDED FUNCTION. DESPITE THE BELL SPRING RETRECTION, THE INVESTIGATION CONCLUDES THAT THE MAIN REASON FOR SLING BAR DETACHMENT IS USER ERROR. THE SLING BAR IS NOT EXPECTED TO DETACH FROM CEILING LIFT UNLESS IT IS ANGLED ET 90 DEGREES FROM THE H ADAPTER, WHICH WOULD NOT OCCUR DURING NORMAL USE. THE INSTRUCTION FOR USE ADVISES THE USER TO INSPECT THE LIFT FOR SIGNS OF WEAR AND DAMAGE AND TO CHECK THE SLING BAR CONNECTION BEFORE USE. HENDICARE SEES NO REESON FOR FURTHER ACTION AT THIS TIME DUE TO USER ERROR, BUT WILL CONTINUE TO MONITOR THIS TYPE OF EVENT.

    Description of Event or Problem · 0

    SLING BAR DETACHED FROM CEILING LIFT AND FELL ONTO THE PATIENT'S CHEST DURING PATIENT TRANSFER FROM WHEELCHAIR TO BED. THE PATIENT WHO WAS ASSSISTED BY TWO CAREGIVERS. PATIENT FELL A SHORT DISTANCE TO THE BED AND DID NOT SUSTAIN ANY INJURY.

    Description of Event or Problem · 1

    SLING BAR DETACHED FROM CEILING LIFT AND FELL ONTO THE PATIENT'S CHEST DURING PATIENT TRANSFER FROM WHEELCHAIR TO BED. THE PATIENT WHO WAS ASSSISTED BY TWO CAREGIVERS. PATIENT FELL A SHORT DISTANCE TO THE BED AND DID NOT SUSTAIN ANY INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760402 RISEATLAS PATIENT LIFTS FSA HANDICARE AB 50100057

    Patients

    Seq Age Sex Outcome Treatment
    1