BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 3250321 · Received July 24, 2013

    Report

    Report Number
    2020362-2013-00322
    Event Type
    Malfunction
    Date Received
    July 24, 2013
    Report Date
    May 10, 2013
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE; THE POWER BUTTON IS NOT MISSING BUT IS TORN. THERE ARE PEN MARKS ON THE CASE AROUND THE POWER BUTTON. HOWEVER, THERE IS BATTERY LEAKAGE RESIDUE ON BATTERY COMPARTMENT WALLS, NO VISIBLE CORROSION ON THE BATTERY DOOR CONTACTS OR BATTERY SPRINGS. UNIT POWERS UP AND PASSES ALL FUNCTIONAL TESTS. POSEY INSTRUCTIONAL LABEL IS TORN AND IS PEELING AND THE MOISTURE INDICATOR LABEL IS MISSING. NOTE: INSTRUCTIONS FOR USE STATE: DO NOT MIX OLD AND NEW BATTERIES OR BATTERY BRANDS. THIS MAY CAUSE RUPTURE OR LEAKAGE AND DAMAGE ALARM. DO NOT ALLOW BATTERIES TO DEPLETE WHILE IN THE ALARM. CHANGE BATTERIES IMMEDIATELY WHEN HEARING THE LOW BATTERY "CHIRP." DEPLETED BATTERIES MAY LEAK AND CORRODE, CAUSING DAMAGE TO THE ELECTRONICS AND RELIABILITY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE POWER BUTTON IS MISSING ON THE ALARM. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345692 SITTER II KMI J. T. POSEY CO. 8281 NA

    Patients

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