BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 3810666 · Received March 24, 2014

    Report

    Report Number
    2020362-2014-00100
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Report Date
    February 4, 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
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE USER'S NOTE; NURSE CALL RECEPTACLE MOVES AS THE NURSE CALL CABLE IS BEING PLUGGED IN BUT THE CABLE FITS AS IT SHOULD IN THE RECEPTACLE. NURSE CALL LIGHT DOES NOT COME ON AT THE NURSE CALL TEST FIXTURE WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD. THE NURSE CALL RECEPTACLE IS PROTRUDING FROM THE ALARM CASE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY DID NOT KNOW WHAT IS WRONG WITH THE ALARM AND HAS NO FURTHER INFO. MORE INFO RECEIVED ON A NOTE WITH THE RETURNED ALARM STATED " CABLE DOES NOT FIT INTO GREEN BOX TIGHTLY SO NURSE CALL WILL NOT LIGHT UP AT THE NURSE STATION". CUSTOMER COULD NOT PROVIDE A DATE WHEN FOUND. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172784 SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK