BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE CALL CABLE

    MDR report key: 4101962 · Received September 15, 2014

    Report

    Report Number
    2020362-2014-00309
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Report Date
    August 13, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE BOTH NURSE CALL CABLE RETURNED FOUND THE NURSE CALL INDICATOR LIGHT AT THE NURSE CALL TEST FIXTURE TOGGLES ON AND OFF WHEN THE NURSE CALL CABLES ARE WIGGLED. THE CABLES WERE OPENED UP AND THEY WERE FOUND TO HAVE A BROKEN GROUND WIRE. THE POSEY WARNING LABEL IS MISSING AND THERE ARE SCUFF MARKS ON THE CABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NURSE'S STATION SOUNDS INCONSISTENTLY WHEN THE ALARMS ARE IN USE WITH THE NURSE CALL CABLES. THIS WAS DISCOVERED DURING USE; HOWEVER, THE CUSTOMER COULD ONLY PROVIDE THE DATE OF THE EVENT. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569122 NURSE CALL CABLE KMI J. T. POSEY CO. 8282 N1203

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SITTER ELITE ALARM: MODEL 8345, SN UNK