BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER ELITE

    MDR report key: 3922114 · Received May 30, 2014

    Report

    Report Number
    2020362-2014-00210
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. THE UNIT DOES NOT SEND A SIGNAL TO ACTIVATE THE RED LED. WHEN THE NURSE CALL RECEPTACLE IS WIGGLED, THE NURSE CALL RED LED TURNS ON AND OFF. THERE IS PHYSICAL DAMAGE TO THE NURSE CALL RECEPTACLE. ADDITIONALLY, UNIT HAS BEEN EXPOSED TO MOISTURE AND THE BATTERY DOOR IS MISSING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM IS SOUNDING, HOWEVER, IT DOES NOT SEND A SIGNAL TO THE NURSE CALL STATION. THE DATE OF THE EVENT IS UNKNOWN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320094 POSEY SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NURSE CALL CABLE, MODEL 8282, LOT # UNK