BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANDERLIFT WITH SCALE

    MDR report key: 2617378 · Received May 18, 2012

    Report

    Report Number
    1317256-2012-00003
    Event Type
    Malfunction
    Date Received
    May 18, 2012
    Date of Event
    March 12, 2012
    Report Date
    May 14, 2012
    Manufacturer
    SR INSTRUMENTS, INC.
    Product Code
    FRW
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SR ASKED FOR THE RETURN OF THE SCALE TO THE LIFT MFR AND THEY REPORTED THAT THE NURSING HOME WAS NOT RESPONDING TO THEIR REQUEST. WE THEN ASKED THE LIFT MFR IF HE HAD ANY MORE CORRESPONDENCE WITH THE NURSING HOME AND THE NURSING HOME'S RESPONSE WAS NO CASUALTIES, NO ONE WAS HURT. THE SCALE "BROKE". A MALFUNCTION WAS REPORTED. PICTURES WERE SENT TO THE LIFT MFR BY THE NURSING HOME, THE PICTURES SHOW THE SCALE WITH THE BROKEN HOOK LAYING NEXT TO IT. MISSING FROM THE PICTURE WAS A SCREW THAT IS USED IN THE HOOK AND A PLASTIC INSERT THAT IS ADDED BY THE LIFT MFR BEFORE SHIPPING TO THE CUSTOMER. THIS PLASTIC INSERT IF NOT USED COULD HAVE CAUSED THE MISUSE OF THE SCALE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE LIFT MFR BY THE NURSING HOME THAT A MALFUNCTION OCCURRED INVOLVING A BROKEN HOOK ON THE SCALE ATTACHED TO THE LIFTER. IT WAS REPORTED THAT THE SCALE WAS NOT IN USE AND NO PT OR STAFF WERE INJURED. PICTURES WERE SENT TO THE LIFT MANUFACTURER BY THE NURSING HOME,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANDERLIFT WITH SCALE PATIENT LIFT WITH SCALE FRW SR INSTRUMENTS, INC. VANDERLIFT W/SCALE

    Patients

    Seq Age Sex Outcome Treatment
    1