BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER PRESENCE LIFTER WITH SCALE

    MDR report key: 2549698 · Received April 11, 2012

    Report

    Report Number
    1317256-2012-00002
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    February 21, 2012
    Report Date
    April 6, 2012
    Manufacturer
    SR INSTRUMENTS (SCALE MANUFACTURER ONLY)
    Product Code
    FRW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT MEDICAL DEVICE INFO: PRESENCE LIFTER 0912L0803. 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, DURING A PATIENT TRANSFER FROM THE CHAIR TO THE BED, THE BRACKET THAT HOLDS THE CRADLE AT THE TOP BROKE. TWO CNA'S LOWERED THE PATIENT TO THE BED. NO INJURIES WERE REPORTED. FOLLOW UP INVESTIGATION REVEALED THAT THE PATIENT DID NOT RECEIVE ANY INJURIES. DESCRIPTION PROVIDED BY THE FACILITY INDICATES THAT THE "DOG EAR" OR MOUNTING BRACKET THAT HOLDS THE SCALE TO THE CRADLE SHEARED. COMPLAINT # (B)(4) HAS BEEN ENTERED INTO THE SYSTEM BY (B)(4) TO RETRIEVE THE LIFT BACK FOR EVALUATION.

    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