BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE FALL MONITOR

    MDR report key: 1821287 · Received August 26, 2010

    Report

    Report Number
    2020362-2010-00200
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Report Date
    July 29, 2010
    Manufacturer
    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). EVAL: RESULTS: EVAL FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED, THE ALARM POWERED ON, BUT THERE'S NO ALARM TONE WHEN THE WEIGHT IS REMOVED FROM THE SENSOR. THE FAIL SAFE FEATURE DID NOT FUNCTION. THE ALARM BATTERY DOOR IS MISSING. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ALARM HAS POWER, BUT WHEN WEIGHT IS REMOVED FROM THE SENSOR THE ALARM DID NOT SOUND. THE BATTERIES WERE REPLACED WITH A NEW SUPPLY. THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI