BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 2434891 · Received January 26, 2012

    Report

    Report Number
    2020362-2012-00039
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Report Date
    January 6, 2012
    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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: EVALUATION OF THE RETURNED PRODUCT REVEALED WHITE POWDER RESIDUE INSIDE THE BATTERY COMPARTMENT WHICH INDICATES BATTERY LEAKAGE. ALSO THERE IS WHITE POWDER RESIDUE BEHIND THE BATTERY DOOR. THE UNIT DID NOT PASS FUNCTIONAL TESTS. THERE WAS NO INTERMITTENCY FOUND WHEN TESTED. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK. ALWAYS INSTALL A COMPLETELY NEW SET OF BATTERIES. DO NOT ALLOW BATTERIES TO DEPLETE WHILE IN THE ALARM. DEPLETED BATTERIES MAY LEAK AND CORRODE, CAUSING DAMAGE TO THE ELECTRONICS AND RELIABILITY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE REASON FOR RETURNING THE ALARM WAS BECAUSE IT SOUNDS INTERMITTENTLY. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI