BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER SELECT

    MDR report key: 3932843 · Received March 11, 2014

    Report

    Report Number
    2020362-2014-00071
    Event Type
    Malfunction
    Date Received
    March 11, 2014
    Report Date
    February 4, 2014
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: EVALUATION OF THE RETURNED PRODUCT REVEALED THAT THE UNIT POWERS UP, BUT THE ALARM SENSOR FUNCTIONS IN REVERSE MODE; THE UNIT SOUNDS WHEN THERE IS WEIGHT ON THE SENSOR PAD AND DOES NOT ALARM WHEN EIGHT IS TAKEN OFF THE PAD. THE NURSES CALLED FUNCTIONS NORMALLY; HOWEVER WHEN THE CABLE IS WIGGLED/MOVED, THE LED BECOMES INTERMITTENT. THE BATTERY SPRINGS ARE BENT, THE AQUALERT WATER INDICATOR LABEL IS TORN, AND THE ALARM CASE IS SCUFFED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER WAS UNABLE TO PROVIDE ANY INFO OTHER THAN THE ALARM IS BROKEN. THE DATE WHEN THE ISSUE WAS DISCOVERED IS UNK. NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146333 SITTER SELECT KMI J. T. POSEY CO. 8361 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MAGNET: MDOEL 8361M, LOT # UNK