BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2051945 · Received March 11, 2011

    Report

    Report Number
    2020362-2011-00063
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Report Date
    January 12, 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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION: RESULTS: EVALUATION OF PRODUCT FOUND THAT THE ALARM DID POWER ON WHEN USING THE 9V AC ADAPTER HOWEVER, DURING EVALUATION IF THE CABLE FROM THE 9V AC ADAPTER WAS MOVED THE POWER WOULD TURN OFF INTERMITTENTLY. THE ALARM DOES NOT POWER ON WHEN USING NEW BATTERIES OR A POWER SUPPLY. THE BATTERY DOOR IS MISSING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS NO POWER WHEN TESTED WITH NEW BATTERIES. THE CUSTOMER REPORTED THAT THERE WERE NO CRACKS, MISSING SCREWS, BUTTONS AND NO LEAKAGE OR CORROSION ON THE ALARM. THERE WAS NO PATIENT INJURY REPORTED. INSPECTION OF THE PRODUCT FOUND THAT THE ALARM WOULD TURN OFF INTERMITTENTLY WHEN POWERED WITH THE 9V AC ADAPTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI