BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARA 3000

    MDR report key: 2223508 · Received July 13, 2011

    Report

    Report Number
    3004468271-2011-00028
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    MEDIBO MEDICAL PRODUCTS NV
    Product Code
    FSA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (REGISTRATION #1419652) ON BEHALF OF THE MANUFACTURER MEDIBO MEDICAL PRODUCTS NV (REGISTRATION #300446821). THE ARJOHUNTLEIGH SERVICE REP FOUND EVIDENCE OF MISUSE, IN WHICH THE LIFT WAS CAUGHT UNDERNEATH SOMETHING DURING THE UPSTROKE OF THE ACTUATOR. THIS CAUSED EXTENSIVE BENDING OF THE LIFTING ARM; THE BENDING OF THE ARM PLACED ADDITIONAL TENSION ON THE BOLTS WHICH OVER TIME CAUSED THEM TO SNAP UNDER LOAD. DURING A SURVEY OF THE ROOM, THE SERVICE REP FOUND THAT THE LIFTING ARM FIT UNDERNEATH A METAL SUPPORT BAR NEAR THE TOILET. ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    (B)(6) WAS TRANSFERRING THE RESIDENT FROM THE SHOWER CHAIR TO THE WHEELCHAIR. THEY PLACED THE RESIDENT IN THE SLING AND BEGAN RAISING THE LIFT AND RESIDENT. AT THAT TIME, THE BOLTS CONNECTING THE LIFTING ARMS TO THE MAST SHEARED OFF. THIS RESULTED IN THE LIFTING ARM AND RESIDENT - WHO WAS ATTACHED TO SLING - TO FALL BACKWARDS AGAINST THE WALL. THE RESIDENT FELL ON HIS BEHIND WHILE BUMPING HIS HEAD AGAINST THE WALL. THE (B)(6) OBTAINED ASSISTANCE AND USED A DIFFERENT DEVICE TO FINISH THE RESIDENT TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SARA 3000 ACTIVE FLOOR LIFT FSA MEDIBO MEDICAL PRODUCTS NV HEA1002-US

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other