BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY SITTER II ALARM

    MDR report key: 2241313 · Received September 2, 2011

    Report

    Report Number
    2020362-2011-00294
    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 HAS INTERMITTENT POWER; THE LCD TURNS ON AND OFF WHEN TESTED. ALSO, THERE IS NO ALARM SOUND. THE UNIT DOES NOT PASS FUNCTIONAL TEST. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CONTINUOUS ALARM TONE WHEN WEIGHT IS APPLIED TO THE SENSOR. THE ALARM WAS TESTED WITH A NEW SENSOR AND THE RESULTS REMAIN THE SAME. THERE IS NO VISIBLE DAMAGE REPORTED TO THE OUTSIDE OF THE ALARM. 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 NA