BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 2478468 · Received February 16, 2012

    Report

    Report Number
    2020362-2012-00076
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Report Date
    January 16, 2012
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THE ALARM POWERS UP BUT THE LOW BATTERY TEST AND THE VOICE MESSAGE FUNCTION FAILED. THE DISPLAY SCREEN HAS A SUBSTANCE ON THE INSIDE OF THE SCREEN AND THE NUMBERS ARE NOT VISIBLE. SENSOR FUNCTION ONLY WORKS ON INITIAL INSTALLATION OF THE BATTERIES AND NOT AFTER THE BUTTONS ARE PRESSED. THE SELECT UP AND DOWN BUTTONS DO NOT WORK. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS POWER BUT THE DISPLAY IS BLANK. ALL OTHER FUNCTIONS OF THE ALARM WORK FINE. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITTER II KMI J. T. POSEY CO. 8281 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LOT NUMBER: UNK| OVER-THE-MATTRESS SENSOR PAD MODEL: 8307,