BEUDAMED
    FDA Adverse Event Death Summary report: N

    POSEY KEEPSAFE FALL MONITOR

    MDR report key: 1662477 · Received April 16, 2010

    Report

    Report Number
    2020362-2010-00089
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    June 23, 2009
    Report Date
    April 9, 2010
    Manufacturer
    DONGGUAN POSEY MEDICAL DEVICE LTD.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - NO PRODUCT MALFUNCTION. PRODUCT WAS DISCARDED AT THE FACILITY. THIS EVENT WAS DUE TO USER ERROR (IN THAT, THE USER CHOSE THE INCORRECT PRODUCT FOR USE ON THIS PT. POSEY DOES OFFER OTHER MORE SUITABLE PRODUCTS FOR PTS THAT REQUIRE DIFFERING LEVELS OF RESTRAINT. THE PRODUCT CHOSEN PERFORMED AS INTENDED, THERE WAS NO PRODUCT MALFUNCTION CLAIMED OR IDENTIFIED). (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM AND AN ALARM SENSOR BELT WERE ON A RESIDENT IN A WHEELCHAIR. THE RESIDENT OPENED THE ALARM SENSOR BELT AND STOOD UP. THE ALARM SOUNDED AS IT SHOULD AND THE STAFF RESPONDED IMMEDIATELY. UNFORTUNATELY, BY THE TIME THEY REACHED THE RESIDENT ("WITHIN A MATTER OF SECONDS"), HE FELL AND ULTIMATELY DIED AS A RESULT OF THE FALL. NOTE: THE CUSTOMER CLARIFIED THAT THE PRODUCTS FUNCTIONED AS INTENDED AND THAT THERE WAS NO PRODUCT MALFUNCTION. THE CUSTOMER ULTIMATELY DISCARDED THE ALARM SENSOR BELT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE FALL MONITOR KMI DONGGUAN POSEY MEDICAL DEVICE LTD. 8350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Death POSEY SEAT BELT SENSOR: MODEL: 8360 SERIAL#: NI