BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER PRESENCE LIFTER WITH SCALE

    MDR report key: 2549697 · Received April 11, 2012

    Report

    Report Number
    1317256-2012-00001
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    January 24, 2012
    Report Date
    April 6, 2012
    Manufacturer
    SR INSTRUMENTS (SCALE MANUFACTURER ONLY)
    Product Code
    FRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT DEVICE INFO: PRESENCE LIFTER 0909L0276. SCALE MODEL FG3105 - SERIAL #(B)(4). THE SCALE MANUFACTURER IS SR INSTRUMENTS, (B)(4). IT WAS REPORTED TO SR INSTRUMENTS FROM (B)(4) THE LIFT MANUFACTURER IS APEX HEALTHCARE MFG. INC., (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER FROM DISTRIBUTOR VIA THE FACILITY. A RESIDENT WAS BEING LIFTED AND THE BRACKET BROKE. THE RESIDENT ENDED UP ON THE FLOOR. THE LAST REPORTED WEIGHT OF THE RESIDENT WAS (B)(6), THE MOUNTING BRACKET FOR THE SLING BAR ON THE HOYER APPEARS TO HAVE SHEARED. THE DEVICE IS IN A LOCKED ENCLOSED AREA. FOLLOW UP INVESTIGATION REVEALED THAT NO SERIOUS INJURY TO THE PATIENT. (B)(4) EVALUATION CONSISTS OF REVIEW OF DIGITAL IMAGES. IT APPEARS THAT THE "DOG EAR" WHERE THE CRADLE ATTACHES TO THE SCALE SHEARED. REPEATED ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT HAVE BEEN INEFFECTUAL. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER PRESENCE LIFTER WITH SCALE PATIENT LIFT WITH SCALE FRW SR INSTRUMENTS (SCALE MANUFACTURER ONLY) PRESENCE/ SCALE

    Patients

    Seq Age Sex Outcome Treatment
    1