BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 3915505 · Received February 25, 2014

    Report

    Report Number
    2020362-2014-00063
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Report Date
    January 7, 2014
    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 RESULTS FOUND THAT THE ALARM DOES NOT SOUND WHEN THE MAGNET IS REMOVED FROM THE MAGNET PLATE OR WHEN NOTHING IS CONNECTED TO ALARM (FAIL SAFE). THE ALARM SOUNDS WHILE USING A SENSOR PAD AND WEIGHT IS REMOVED FROM THE SENSOR PAD. THE UNIT PASSES ALL OTHER FUNCTIONAL TESTS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM CONTINUOUSLY SOUNDS WHEN IN USE WITH THE STRING CLIP MAGNET. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY. CUSTOMER DID NOT PROVIDE A DATE WHEN ISSUE WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116109 SITTER ELITE KMI J. T. POSEY CO. 8345 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA SITTER ELITE MAGNET: PART # 8345M, LOT # UNK