BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE FALL MONITOR

    MDR report key: 1914032 · Received November 19, 2010

    Report

    Report Number
    2020362-2010-00354
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Report Date
    August 10, 2010
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: EVAL FOR THE RETURNED PRODUCT SHOWS THAT WHEN TESTED WITH NEW BATTERIES, THE ALARM POWERED ON, BUT THERE'S NO ALARM TONE. THE FAIL SAFE, TONE SELECTOR, AND THE LOW BATTERY INDICATOR FEATURES DO NOT WORK. THE UNIT BATTERY DOOR IS MISSING. THE ALARM CASE HAS NO VISIBLE DAMAGE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CLAIMS THAT THE ALARM DOES NOT POWER ON. THE BATTERIES WERE REPLACED AND THE RESULTS REMAIN THE SAME. THERE IS NO VISIBLE DAMAGE ON THE OUTSIDE OF THE ALARM. THE BATTERY DOOR CLOSES PROPERLY. THERE WAS NO PT INCIDENT OR INJURY REPORTED. EVAL FOR THE RETURNED PRODUCT SHOWS THE ALARM DOES POWER ON, BUT THERE IS NO ALARM TONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE FALL MONITOR KMI J. T. POSEY CO. 8350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI