BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2922726 · Received December 28, 2012

    Report

    Report Number
    2020362-2012-00699
    Event Type
    Malfunction
    Date Received
    December 28, 2012
    Report Date
    December 4, 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
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE OF ALARM NOT POWERING ON WITH NEW BATTERIES. THE ALARM HAS BATTERY CORROSION ON THE BATTERY CONTACTS. THE ALARM POWERS ON WITH A 9V ADAPTER OR WHEN USING AN EXTERNAL POWER SUPPLY AND PASSES ALL FUNCTIONAL TESTS. NOTE: INSTRUCTIONS FOR USE HAS A WARNING STATEMENT ON BATTERY INSTALLATION: TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. ALWAYS INSTALL A COMPLETELY NEW SET OF BATTERIES WHEN THE CHIRPING DUE TO LOW BATTERY POWER SOUND BEGINS. 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 THE ALARM WILL NOT POWER ON EVEN AFTER THE BATTERIES WERE REPLACED WITH NEW ONES. THE CUSTOMER REPORTED THAT ARE NO SIGNS OF BATTERY LEAKAGE OR CORROSION IN THE BATTERY COMPARTMENT. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS OCCURRED. 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 SQUARE CHAIR SENSOR PAD: MODEL 8308, LOT # UNK