BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOYER PRESENCE LIFT WITH SCALE

    MDR report key: 2512483 · Received March 27, 2012

    Report

    Report Number
    2182305-2012-00009
    Event Type
    Malfunction
    Date Received
    March 27, 2012
    Date of Event
    February 21, 2012
    Report Date
    March 22, 2012
    Manufacturer
    SR INSTRUMENTS
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCALE MANUFACTURER IS SR INSTRUMENTS, (B)(4). THE LIFT MANUFACTURER IS APEX HEALTHCARE MFG. INC.,(B)(4). JOERNS IS SENDING REPORT TO LIFT MANUFACTURER. JOERNS IS SENDING REPORT TO SCALE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE MANUFACTURER, BY FACILITY, PER FACILITY, DURING STANDARD PATIENT TRANSFER FROM THE CHAIR TO THE BED, THE BRACKET THAT HOLDS CRADLE AT TOP BROKE. TWO CNAS LOWERED PATIENT INTO BED. NO INJURIES WERE REPORTED. FOLLOW UP REVEALED THAT THE PATIENT DID NOT RECEIVE ANY INJURIES. DESCRIPTION PROVIDED BY FACILITY INDICATES THAT THE "DOG EAR" OR MOUNTING BRACKET THAT HOLDS THE SCALE TO THE CRADLE SHEARED. THE SCALE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION OR CONFIRMATION AS OF THIS WRITING. (B)(4) ENTERED INTO SYSTEM TO RETRIEVE THE LIFT BACK FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOYER PRESENCE LIFT WITH SCALE PATIENT LIFT WITH SCALE FNG SR INSTRUMENTS PRESENCE / SCALE

    Patients

    Seq Age Sex Outcome Treatment
    1