BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE ALARM

    MDR report key: 2241326 · Received September 2, 2011

    Report

    Report Number
    2020362-2011-00304
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Report Date
    August 10, 2011
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ALARM, FAILURE TO. EVAL RESULTS: EVAL OF THE RETURNED PRODUCT SHOWS THE ALARM POWERS ON AND THERE WAS NO ALARM SOUND WHEN WEIGHT WAS TAKEN OFF THE SENSOR PAD. THE UNIT IS MISSING THE BATTERY DOOR. THE UNIT DOES NOT PASS FUNCTIONAL TESTS. NOTE: POSEY INSTRUCTIONS FOR USE AND PROPER HANDLING. IF THE POSEY KEEPSAFE IS SUBJECTED TO SEVERE MECHANICAL SHOCK, SUCH AS DROPPING, OR IS SUBMERGED IN LIQUID, IT MAY STOP FUNCTIONING AS DESIGNED. VISUALLY INSPECT THE UNIT FOR CRACKS IN THE CASE, MISSING SCREWS, MISSING BATTERY DOOR, BROKEN WIRES OR SIGNS OF EXPOSURE TO LIQUID. AFTER EACH INCIDENT, YOU MUST VERIFY THAT THE UNIT IS WORKING PROPERLY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM THE SENSOR. THE BATTERIES WERE REPLACED WITH A NEW SUPPLY AND ALL OF THE SAME TYPE. THE ALARM WAS TESTED WITH A NEW SENSOR AND THE RESULTS REMAIN THE SAME. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA