BEUDAMED
    FDA Adverse Event Other Summary report: N

    MAXI MOVE

    MDR report key: 2243540 · Received July 6, 2011

    Report

    Report Number
    9611530-2011-00053
    Event Type
    Other
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ARJO HOSPITAL EQUIPMENT AB
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH (REGISTRATION (B)(4)) ON BEHALF OF THE MANUFACTURER ARJO HOSPITAL EQUIPMENT (B)(4) (REGISTRATION #(B)(4)). THE ARJOHUNTLEIGH SALES REP REPORTED AFTER INTERVIEWING STAFF MEMBERS, THAT TWO CAREGIVERS WERE PRESENT AND NOT WATCHING RESIDENT CLOSELY. FACILITY OT MADE RECOMMENDATIONS TO STAFF AND RETRAINED. THE TYPES OF PTS THE FACILITY SEES MOVE AROUND ERRATICALLY WITHIN THE SLINGS. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    RESIDENT WAS IN RECLINING POSITION IN AN AMPUTEE SLING AND PUT ALL HIS WEIGHT ON ONE SIDE OF THE SLING. RIGHT SHOULDER SLING CLIP POPPED OFF THE SPREADER BAR. RESIDENT FELL ONTO THE FLOOR, HITTING THEIR BACK. TAKEN TO MEDICAL CENTER, NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXI MOVE PASSIVE FLOOR LIFT FNG ARJO HOSPITAL EQUIPMENT AB KMBB4MLU2FUS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization