BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE NO POWER

    MDR report key: 2478477 · Received February 16, 2012

    Report

    Report Number
    2020362-2012-00077
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Report Date
    November 13, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) BATTERY LEAKAGE, CORROSION. EVALUATION OF THE RETURNED PRODUCT FOUND THE UNIT DID NOT POWER UP WHEN TESTED WITH BATTERIES. FURTHER INVESTIGATION REVEALED THE BATTERY DOOR HAS CORROSION AND BATTERY LEAKAGE. THE UNIT POWERED UP WITH A POWER SUPPLY AND APPEARS TO WORK. 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 THE ALARM HAS BATTERY CORROSION. THERE WAS NO PATIENT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA