BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 1883024 · Received October 22, 2010

    Report

    Report Number
    2020362-2010-00304
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Report Date
    September 21, 2010
    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

    (B)(4). EVALUATION RESULTS: EVALUATION OF THE RETURNED PRODUCT FOUND THAT THE ALARM HAS POWER BUT THE LCD DISPLAY GOES BLANK WHEN PRESSURE IS TAKEN OFF THE PAD AND THE SOUND BEGINS TO DIE OUT GRADUALLY. THE LED INDICATORS DO NOT WORK. THERE IS NO VISIBLE DAMAGE TO THE UNIT. THE 8308 SENSOR PAD WAS NOT RETURNED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS NO POWER WHEN TESTED WITH NEW BATTERIES. THERE IS NO DAMAGE TO THE BATTERY DOOR AND NO WIRES ARE LOOSE. THEY ARE USING THE 8308 SENSORS WITH THE ALARM. THERE WAS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. THERE WAS NO PATIENT INJURY REPORTED. INSPECTION SHOWS THAT THE LCD DISPLAY GOES BLANK WHEN PRESSURE IS TAKEN OFF OF THE PAD AND THE SOUND BEGINS TO DIE OUT GRADUALLY. THE LED INDICATORS DO NOT WORK.

    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 SQUARE CHAIR SENSOR PAD: MODEL 8308| LOT NUMBER: UNK