BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT

    MDR report key: 868104 · Received June 19, 2007

    Report

    Report Number
    2182305-2007-00021
    Event Type
    Other
    Date Received
    June 19, 2007
    Date of Event
    May 28, 2007
    Report Date
    June 15, 2007
    Manufacturer
    IMS INC, INTEGRATED MEASURMENT SYSTEM
    Product Code
    FSA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURER BY FACILITY, PER FACILITY, THEY WERE DOING A TWO PERSON ASSIST TRANSFER FROM BED TO WHEEL CHAIR. RESIDENT WAS LIFTED STRAIGHT UP OVER THE BED WHEN THE LIFT PART SNAPPED CAUSING THE RESIDENT TO FALL BACK ON TO THE BED. NO INJURY TO RESIDENT. THE PART RIGHT ABOVE THE SCALE WHERE IT ATTACHES TO THE BOOM SNAPPED OFF PER FACILITY. BECAUSE THIS IS THE 4 POINT CRADLE WITH SCALE RECALL ISSUE, THEIR DEALER D.S. SHOULD HAVE CONTACTED THEM ABOUT THE RECALL. MANUFACTURER INFORMED HER THAT THE 4 POINT CRADLE WITH SCALE WAS RECALLED AND WE NEEDED BOTH THE 4 POINT CRADLE AND ITS SCALES SENT BACK TO US. WE EXPLAINED THAT THIS WILL MEAN THE CRADLE AND SCALE INVOLVED IN THE INCIDENT AS WELL AS THE CRADLE AND SCALE THAT WAS ON THE SECOND LIFTER. WE WILL SEND HER [2] 4 POINT CRADLES; PLAIN, ALONG WITH A 6 POINT CRADLE WITH SCALE AND SLINGS WHICH GO WITH THE 6 POINT CRADLE SO SHE CAN WEIGH THEIR RESIDENTS. WHEN THE APPROVED RE-DESIGN IS COMPLETED [ETA END OF JUNE 2007] FOR THE 4 POINT CRADLE WITH SCALE WE WILL SEND THEM NEW 4 POINT CRADLES WITH SCALES. MANUFACTURER ISSUED RMA TO GET ITEMS BACK FOR EVALUATION. IMS SCALE MANUFACTURER ALSO NOTIFIED OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT PATIENT LIFTER FSA IMS INC, INTEGRATED MEASURMENT SYSTEM PRESENCE W/SCALE

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other