BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAND HELD NURSE CALL DEVICE

    MDR report key: 11521 · Received February 16, 1994

    Report

    Report Number
    MW1000749
    Event Type
    Malfunction
    Date Received
    February 16, 1994
    Date of Event
    February 10, 1994
    Report Date
    February 11, 1994
    Manufacturer
    RAULAND-BORG CORP.
    Product Code
    ILQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PLASTIC THAT COVERS THE INTERNAL WIRES ON THE RN CALL DEVICE HAS BECOME SEPARATED FROM THE CONTROL DEVICE HOUSING THEREBY EXPOSING THE INNER COVERED WIRES. RPTR HAS SEEN THIS OCCUR WITH A NUMBER OF THESE UNITS. AT LEAST TEN HAVE HAD TO BE REPLACED AND MORE ARE GOING TO HAVE TO BE REPLACED. THE DEVICES ARE UL APPROVIED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAND HELD NURSE CALL DEVICE ILQ RAULAND-BORG CORP. ES-11

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other