BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE NO-POWER SWITCH

    MDR report key: 2081620 · Received April 13, 2011

    Report

    Report Number
    2020362-2011-00118
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Report Date
    March 15, 2011
    Manufacturer
    J. T. POSEY COMPANY
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - WHITE POWDER SUBSTANCE ON BATTERY AND BATTERY COMPARTMENT. THE PRODUCT HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED FOR INVESTIGATION. NOTE: THE INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: DO NOT MIX OLD AND NEW BATTERIES OR BATTERY BRANDS. THIS MAY CAUSE RUPTURE OR LEAKAGE AND MAY DAMAGE THE ALARM. NOTE: THIS SUBMISSION IS BASED SOLELY ON THE USER FACILITY STATEMENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS POWER. HOWEVER, THEY NOTICED WHITE DUST HAS DEVELOPED ON THE BATTERIES AND HAS RESULTED IN THE BATTERIES STICKING TOGETHER. THE CUSTOMER DID NOT FEEL COMFORTABLE WITH CLEANING THE BATTERY COMPARTMENT AND REPLACING THE BATTERIES. CUSTOMER IS UNSURE IF THE BATTERIES HAVE BEEN REPLACED OR IF THEY WERE MIXED WITH OLD OR NEW BATTERIES. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POSEY KEEPSAFE DELUXE NO-POWER SWITCH KMI J. T. POSEY COMPANY 8374NP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI