BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE CALL CABLE

    MDR report key: 4101953 · Received September 15, 2014

    Report

    Report Number
    2020362-2014-00300
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE NURSE CALL CABLE WAS TESTED WITH BOTH THE CUSTOMER'S ALARM AND A KNOWN WORKING ALARM. WHEN THE CABLE IS MOVED IN EITHER DEVICE, THE NURSE CALL INDICATOR LIGHT TOGGLES ON AND OFF. IT WAS FOUND THAT THE GROUND WIRE IS BROKEN INSIDE THE NURSE CALL CABLE. THERE ARE SCUFF MARKS ON THE NURSE CALL CABLE. SEE MANUFACTURE REPORT #2020362-2014-00299 FOR THE ALARM REPORT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NURSE'S STATION SOUNDS INCONSISTENTLY WHEN THE ALARM IS IN USE WITH THE NURSE CALL CABLE. THE CUSTOMER REPORTED THIS WAS DISCOVERED DURING USE, BUT COULD NOT PROVIDE A DATE OF EVENT. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569120 NURSE CALL CABLE KMI KMI J. T. POSEY CO. 8282 N1147

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SITTER ELITE: MODEL 8345, SN: (B)(4)