BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2725437 · Received August 22, 2012

    Report

    Report Number
    2020362-2012-00500
    Event Type
    Malfunction
    Date Received
    August 22, 2012
    Report Date
    July 23, 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
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: EVAL OF THE RETURNED PRODUCT REVEALED THE UNIT DOES POWER ON. ALTHOUGH THE VOICE MESSAGE PLAYS WITH STATIC, THE UNIT PASSES ALL FUNCTIONAL TESTS. ADDITIONALLY THERE IS BATTERY LEAKAGE RESIDUE ON THE BATTERY DOOR, SPRING, AND BATTERY RIBBON. THE BATTERY SPRINGS ARE CORRODED DUE TO BATTERY LEAKAGE. 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

    THE CUSTOMER REPORTED THAT THE ALARM HAS MULTIPLE DAMAGES TO IT. THE CUSTOMER DID NOT KNOW THE SPECIFIC PRODUCT ISSUE OR WHEN THE ISSUE WAS IDENTIFIED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    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 UNK