BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER ELITE

    MDR report key: 4180379 · Received October 15, 2014

    Report

    Report Number
    2020362-2014-00334
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    October 7, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE ALARM FOUND THE NURSE CALL RECEPTACLE HOSING IS LOOSE; HOWEVER, THE INTERNAL MECHANISM IS STILL INTACT. WHEN THE NURSE CALL CABLE IS PLUGGED INTO THE RECEPTACLE AND MOVE, THE NURSE CALL LIGHT TOGGLES ON AND OFF. THE CABLE DOES NOT HAVE A SECURE FIT. IF THE CABLE IS NOT MOVED, THE NURSE CALL LIGHT COMES ON AS IT SHOULD. PHYSICAL INSPECTION OF THE ALARM CASE FOUND THAT THERE ARE CRACKS ON THE DUST COVERS OUTSIDE THE BATTERY COMPARTMENT AND THERE IS A RATTLING SOUND FROM THE INSIDE OF THE UNIT WHICH INDICATES UNIT HAS BEEN DROPPED WHICH GOES AGAINST THE INSTRUCTIONS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THE NURSE CALL CABLE IS PLUGGED INTO THE NURSE CALL OUTLET, IT DOES NOT HAVE A TIGHT FIT. CUSTOMER REPORTED IT WAS DISCOVERED DURING SET UP, BUT COULD NOT PROVIDE THE DATE OF EVENT. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655833 POSEY SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA