BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 1893959 · Received November 3, 2010

    Report

    Report Number
    2020362-2010-00320
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Report Date
    September 30, 2010
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: EVALUATION OF THE PRODUCT FOUND THAT THE ALARM DOES POWER ON HOWEVER, THERE IS NO SOUND WHEN THE VOLUME IS INCREASED AT ANY VOLUME LEVEL SETTING. THE ALARM CASE HAS DAMAGE BY THE BATTERY COMPARTMENT. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT "IF THE UNIT IS SUBJECTED TO SEVERE MECHANICAL SHOCK SUCH AS DROPPING THE UNIT, OR IS SUBMERGED IN LIQUID, THE UNIT MAY STOP FUNCTIONING AS DESIGNED." (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS POWER BUT THE VOLUME WILL NOT INCREASE WHEN SELECTED. THERE WAS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM CASE. THERE WAS NO PATIENT INJURY. INSPECTION OF THE PRODUCT FOUND THAT THE ALARM POWERS ON BUT THERE IS NO SOUND WHEN THE VOLUME IS INCREASED AT ANY VOLUME LEVEL SETTING.

    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 OVER-THE-MATTRESS SENSOR PAD: MODEL #8307,| LOT NUMBER: NI.