BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE CALL CABLE

    MDR report key: 4101960 · Received September 15, 2014

    Report

    Report Number
    2020362-2014-00306
    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 FOUND THAT DURING TESTING, THE NURSE CALL CABLE WITH THE ALARM, WHEN THE NURSE CALL CABLE IS WIGGLED, THE NURSE CALL LIGHT TOGGLES ON AND OFF AT THE TEST FIXTURE. WHEN THE NURSE CALL CABLE IS USED WITH A KNOWN GOOD ALARM, THE NURSE CALL LED TURNS ON AT THE NURSE CALL TEST FIXTURE WHEN THERE IS NO WEIGHT ON THE SENSOR (AS EXPECTED) AND THE NURSE CALL LED TURNS OFF WHEN WEIGHT IS ON THE SENSOR (AS EXPECTED). HOWEVER, IF THE CABLE IS WIGGLED, THE NURSE CALL LED LIGHT TOGGLES ON AND OFF. THE NURSE CALL CABLE WAS SCUFF MARKS ON IT AND ONE OF THE JACKS IS LOOSE. WHEN THE NURSE CALL CABLE WAS OPENED, IT WAS FOUND TO HAVE A BROKEN GROUND WIRE. (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, DISCOVERED WHILE IN USE BUT CUSTOMER COULD NOT PROVIDE THE DATE OF THE EVENT. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569317 NURSE CALL CABLE KMI J. T. POSEY CO. 8282 N1147

    Patients

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