BEUDAMED
    FDA Adverse Event Other Summary report: N

    HOYER LIFT W/SCALE

    MDR report key: 1780897 · Received July 23, 2010

    Report

    Report Number
    1317256-2010-00003
    Event Type
    Other
    Date Received
    July 23, 2010
    Date of Event
    June 8, 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 CONTINUING, TESTING CONTINUING TO DUPLICATE THE FAILURE MODE. (B)(6) DOING A RECALL OF ALL UNITS IN THE FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MANUFACTURING BY THE DISTRIBUTOR VIA THE FACILITY. PER THE FACILITY THE RESIDENT WAS PUT IN THE SLING AND THE SLING WAS ATTACHED TO THE LIFT, THEY HAD JUST STARTED TO DO THE TRANSFER WHEN THE LIFT BROKE, THEY HEARD A SNAP AND THE CRADLE TO THE SCALE BROKE CAUSING THE RESIDENT TO FALL BACK ON THE BED AND THE LIFT CRADLE FELL ONTO HER RESULTING IN THE INJURY. THE FACILITY AND DOCTOR ASSESSED THE RESIDENT AND SHE WAS COMPLAINING OF PAIN IN THE CHEST, SHOULDER AND THE KNEES, THE RESIDENT RATED HER PAIN ON A SCALE FROM 1 TO 10 AS AN 8. THE DISTRIBUTOR ISSUED AND RA TO HAVE THE SCALE AND CRADLE RETURNED, HOWEVER, THEY CHANGED THEIR MIND AND LEGAL COUNCIL WAS RETAINED, THEY WILL NOT RELEASE THE COMPONENTS IN QUESTION.

    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