BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE CALL CABLE /W ADAPTER

    MDR report key: 3770350 · Received February 18, 2014

    Report

    Report Number
    2020362-2014-00044
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Report Date
    November 5, 2013
    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
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED SEVEN NURSE CALL CABLES REVEALED THAT SIX CABLES PASS THE FUNCTIONAL TESTS AND ONLY ONE CABLE DID NOT PASS FUNCTIONAL TESTS. THE CABLE Y CONNECTOR RIGHT SOCKET FUNCTIONS AS EXPECTED. HOWEVER, THE LEFT SOCKET IS LOOSE AND WHEN TESTED, THE NURSE CALL LED DID NOT COME ON AT THE NURSE CALL TEST FIXTURE WHEN WEIGHT WAS REMOVED FROM THE SENSOR PAD. OPENED THE ADAPTER COVER AND OBSERVED A BROKEN WIRE, AFTER THE WIRE WAS RE-SOLDER THE NURSE CALL WORKED AS EXPECTED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE NURSE CALL CABLES ARE NOT SENDING A SIGNAL TO THE NURSE CALL STATION. THE DATE WHEN THE ISSUE WAS DISCOVERED IS UNK. CUSTOMER PROVIDED LIMITED INFO. NO PT INCIDENT OR SERIOUS INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103157 NURSE CALL CABLE /W ADAPTER KMI J. T. POSEY CO. 8235NCS 3064A25

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARM SITTER ELITE, PN 8345, SERIAL # UNK