BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2505025 · Received March 1, 2012

    Report

    Report Number
    2020362-2012-00109
    Event Type
    Malfunction
    Date Received
    March 1, 2012
    Report Date
    January 24, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: EVALUATION OF THE RETURNED PRODUCT REVEALED THAT THERE WAS BATTERY LEAKAGE IN THE BATTERY COMPARTMENT AND ON THE SPRINGS AND CONTACTS. THE UNIT DID NOT POWER ON. THE UNIT HAD A MISSING BATTERY DOOR. NOTE: IFU WARNING STATEMENT FOR BATTERY INSTALLATION: TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. DO NOT REPLACE A SINGLE CELL, BUT ALL CELLS IN THE ALARM. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK (4 BATTERIES). USE OF MIXED BATTERIES OR BATTERIES INSTALLED INCORRECTLY MAY CAUSE BATTERY DAMAGE, AND MAY DAMAGE THE ALARM. REMOVE ANY ALARM FROM USE AND SEND TO THE APPROPRIATE FACILITY AUTHORITY IF BATTERIES ARE DAMAGED OR CORRODED OR THE BATTERY COMPARTMENT HAS SIGNS OF PREVIOUS BATTERY CORROSION SUCH AS WHITE POWDER RESIDUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THEY HAVE AN ALARM THAT HAS DAMAGES BUT COULDN¿T PROVIDE EXACTLY WHAT THE PRODUCT ISSUE WAS. THEY REPORTED POSSIBLY THE ALARM MIGHT HAVE CORROSION AND OR THE HOLD/SUSPEND BUTTON IS COMING OFF BUT THEY COULDN¿T BE MORE SPECIFIC FOR THE REASON OF THE RETURN OF THE ALARM. THE CUSTOMER REPORTED THEY ARE CLEANING THE ALARM WITH SUPER SANI WIPES AND ARE NOT REUSING THE BATTERIES BETWEEN PTS. THERE WAS NO PT 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