BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NURSE CALL CABLE

    MDR report key: 4101955 · Received September 15, 2014

    Report

    Report Number
    2020362-2014-00304
    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: EVALUATION OF THE RETURNED NURSE CALL CABLE AND ALARM FOUND THAT THE NURSE CALL INDICATOR LIGHT TURNS ON AT THE NURSE CALL TEST FIXTURE WHEN THERE IS NO WEIGHT ON THE SENSOR AND THE LIGHT TURNS OFF WHEN WEIGHT IS ON THE SENSOR PAD. HOWEVER, WHEN THE NURSE CALL CABLE IS WIGGLED WHILE PLUGGED INTO THE RECEPTACLE, THE NURSE CALL INDICATOR LIGHT TOGGLES ON AND OFF. THE GROUND WIRE IS BROKEN INSIDE THE CABLE. THERE ARE SCUFF MARKS ON THE NURSE CALL CABLE. ONE OF THE NURSE CALL JACKS IS LOOSE AND TURNS WHEN IT SHOULD NOT. SEE MANUFACTURE REPORT #2020362-2014-00303 FOR ALARM REPORT. (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569136 NURSE CALL CABLE KMI KMI J. T. POSEY CO. 8282 N1147

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK POSEY SITTER ELITE ALARM: MODEL: 8245, SN: (B)(4)