BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT W/SCALE

    MDR report key: 1780899 · Received July 23, 2010

    Report

    Report Number
    1317256-2010-00002
    Event Type
    Other
    Date Received
    July 23, 2010
    Date of Event
    April 23, 2010
    Report Date
    July 22, 2010
    Manufacturer
    SR INSTRUMENTS, INC. (SCALE MANUFACTURER ONLY)
    Product Code
    FRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TELEPHONE CONFERENCES WERE INITIATED BETWEEN (B)(6) AND SR INSTRUMENTS. TESTING INITIATED TRYING TO REPRODUCE THE MODE OF FAILURE, TO DETERMINE IF THE DEVICE WAS USED PROPERLY OR AS INTENDED. SR INSTRUMENTS DOING MATERIAL TESTING, VERIFIED STEELS HEAT TREATING PROCESSES AND VERIFIED MATERIAL TYPE. (B)(4) PERFORMING SAFETY PERFORMANCE TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURING BY THE DISTRIBUTOR VIA THE FACILITY. USING THE REPLACEMENT PT LIFTER SENT, THE SAME AREA FAILED IE THE BOLT/PIN COMING UP THROUGH THE CRADLE TO THE SCALE BROKE, CAUSING THE ASSEMBLY TO TILT AND THEN A DOG EAR PIECE BROKE OFF RESULTING IN THIS FALL. THE PT FELL BACK ONTO THE BED, HOWEVER, THE PT WAS INJURED WHEN THE CRADLE LANDED ON TOP OF HER RESULTING IN THE INJURY, RA ISSUED FOR THE RETURN OF PARTS. THE DISTRIBUTOR ISSUED A CAPA (B)(4) TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER LIFT W/SCALE PATIENT LIFTER W/SCALE FRW SR INSTRUMENTS, INC. (SCALE MANUFACTURER ONLY) HPL700 W/SCALE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization