BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER II ALARM

    MDR report key: 2010038 · Received March 2, 2011

    Report

    Report Number
    2020362-2011-00047
    Event Type
    Malfunction
    Date Received
    March 2, 2011
    Report Date
    February 4, 2011
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS - EVAL FOR THE RETURNED PRODUCT SHOWS WHEN TESTED USING THE CUSTOMER'S BATTERIES THE ALARM HAS INTERMITTENT POWER. WHEN USING NEW BATTERIES THE ALARM POWERS ON, BUT DOES NOT SOUND THE ALARM WHEN PRESSURE IS TAKEN OFF THE SENSOR PAD OR WHEN THE SENSOR IS DETACHED. THE NURSE CALL FUNCTION AND POWER BUTTON PASSED TESTS. THE ALARM DOOR IS BROKEN AND IT CAN BE SLID OUT AWAY FROM THE ALARM CASE. THE POSEY INSTRUCTIONS FOR USE HAS A WARNING: THE ALARM IS AN ELECTRONIC DEVICE THAT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED (BROKEN) OR IMMERSED IN LIQUID. THE UNIT MAY STOP FUNCTIONING AS DESIGNED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ALARM HAS POWER, BUT THE ALARM TONE IS INTERMITTENT WHEN PRESSURE IS RELEASED OFF THE SENSOR PAD. THE BATTERY DOOR CLOSES PROPERLY. THERE ARE NO MISSING BUTTONS OR SCREWS. THERE IS NO BATTERY CORROSION OR LEAKAGE DETECTED. IT'S UNK WHEN THE PRODUCT ISSUE WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI