BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 2241282 · Received September 2, 2011

    Report

    Report Number
    2020362-2011-00291
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    July 18, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: EVAL OF THE RETURNED PRODUCT SHOWS THE ALARM POWERS UP, BUT THE LED LIGHTS DO NOT COME ON. WHEN WEIGHT IS REMOVED FROM THE SENSOR PAD THERE IS STATIC NOISE, AND THEN THE LCD GOES BLANK AND NO SOUND. EXTERNAL POWER SUPPLY SHOWS THE LOW BATTERY INDICATOR DOES NOT WORK. THERE IS NO VISIBLE DAMAGE TO THE UNIT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ALARM HAS NO POWER. THE BATTERIES WERE REPLACED WITH A NEW SUPPLY AND ALL OF THE SAME TYPE. 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 NA