BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE NO POWER SWITCH

    MDR report key: 1821289 · Received August 26, 2010

    Report

    Report Number
    2020362-2010-00188
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Report Date
    June 22, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS - INSPECTION OF THE RETURNED PRODUCT FOUND THAT THE POWER IS INTERMITTENT WHEN USING NEW BATTERIES BUT NOT WHEN USING THE AC ADAPTER. THE BATTERY DOOR IS MISSING AND THERE IS BATTERY ACID LEAKAGE AND CORROSION IN THE BATTERY COMPARTMENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ALARM HAS NO POWER WHEN TEST WITH NEW BATTERIES. BATTERY CONNECTORS ARE INTACT. THE BATTERY DOOR IS MISSING FROM THE ALARM. NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM CASE. THERE WAS NO PT INJURY REPORTED. INSPECTION OF THE PRODUCT FOUND THAT THE POWER IS INTERMITTENT ON THE ALARM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI