BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE FALL MONITOR

    MDR report key: 1851308 · Received September 23, 2010

    Report

    Report Number
    2020362-2010-00241
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Report Date
    August 25, 2010
    Manufacturer
    DONGGUAN POSEY MEDICAL DEVICE LTD.
    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). ALARM, FAILURE TO. THE PRODUCT HAS BEEN REQUESTED TO BE RETURNED BUT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THE ALARM HAS POWER BUT NO ALARM TONE WHEN PRESSURE IS OFF THE PAD. ALSO, NO ALARM TONE WHEN THE SENSOR IS DETACHED FROM THE ALARM. CUSTOMER TESTED WITH NEW CHAIR PAD AND NEW BATTERIES. THIS WAS DISCOVERED WHILE IN USE WITH A PT. THERE WAS NO PT INCIDENT OR INJURY THAT OCCURRED.

    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