BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER II

    MDR report key: 2051947 · Received March 11, 2011

    Report

    Report Number
    2020362-2011-00060
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Report Date
    February 10, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: THE ALARM HAS POWER AND WHEN PRESSURE IS TAKEN OFF THE SENSOR PAD THE ALARM BEGINS TO SOUND BUT THEN THE ALARM SLOWLY POWERS OFF AND BECOMES SILENT AFTER ABOUT 3 SECONDS. THE ALARM HAS THE SAME RESULTS WHEN USING A POWER SUPPLY. THE ALARM WAS TESTED WITH A WORKING 8307 SENSOR. THE LIQUI LABEL IS MISSING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS POWER BUT THERE IS NO ALARM TONE WHEN PRESSURE IS OFF THE SENSOR PAD OR WHEN THE SENSOR PAD IS DETACHED FROM THE ALARM. THERE WAS NO PHYSICAL DAMAGE TO THE ALARM. THERE WAS NO PATIENT 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 NI OVER-THE-MATTRESS SENSOR PAD: MODEL 8307, LOT# UNK