BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VEGA SLINGBAR M

    MDR report key: 7845830 · Received September 5, 2018

    Report

    Report Number
    3009481053-2018-00038
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    August 18, 2018
    Report Date
    May 6, 2019
    Manufacturer
    HANDICARE AB
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE SLINGBAR IS DESIGNED FOR 300KG SAFE WORKING LOAD, THE LIFT IS DESIGNED FOR 230KG SAFE WORKING LOAD. THIS MEANS THAT THE MAX LOAD CAN'T HAVE BEEN EXCEEDED. THE CUSTOMER THINKS THAT THE SLINGBAR WAS DAMAGED WHEN TRANSPORTING THE LIFT BETWEEN LOCATIONS. HANDICARE BELIEVES THAT TO BE A PLAUSIBLE ROOT CAUSE, SINCE A UNDAMAGED SLINGBAR SHOULD NOT BRAKE WHEN USED PROPERLY. FURTHERMORE THIS IS THE ONLY REPORTED CASE OF A BROKEN SLINGBAR HOOK.

    Description of Event or Problem · 0

    THE SLING BAR OF PATIENT FLOOR LIFT FRACTURED DURING USE IN PATIENT'S HOME, CAUSING THE PATIENT TO FALL OFF THE SLING SHEET. THE PATIENT SUSTAINED A FRACTURE TO THE ARM PROPER, TWO ABRASIONS TO THE HEAD AND LARGE BRUISES ON THE BACK.

    Description of Event or Problem · 1

    THE SLING BAR OF PATIENT FLOOR LIFT FRACTURED DURING USE IN PATIENT'S HOME, CAUSING THE PATIENT TO FALL OFF THE SLING SHEET. THE PATIENT SUSTAINED A FRACTURE TO THE ARM PROPER, TWO ABRASIONS TO THE HEAD AND LARGE BRUISES ON THE BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688501 VEGA SLINGBAR M PATIENT LIFTS FSA HANDICARE AB 70200002 2016/08

    Patients

    Seq Age Sex Outcome Treatment
    1