BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 2914851 · Received December 7, 2012

    Report

    Report Number
    2020362-2012-00673
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 16, 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
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED UNIT DID NOT CONFIRM THE REPORTED ISSUE OF NO POWER. THE UNIT POWERED ON WHEN USING THE CUSTOMER'S BATTERIES OR AN EXTERNAL POWER SUPPLY. THERE IS BATTERY LEAKAGE RESIDUE ON THE BATTERY DIAGRAM INSIDE BATTERY COMPARTMENT. NO VISIBLE LEAKAGE OR CORROSION TO THE BATTERY SPRINGS OR FLAT CONTACTS. UNIT WAS TESTED A TOTAL OF THREE TIMES AT FIVE MINUTE INTERVALS AND NO INTERMITTENCY WAS DETECTED. UNIT PASSES ALL FUNCTIONAL TESTS. NOTE: INSTRUCTIONS FOR USE STATE: 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. 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

    CUSTOMER REPORTED THE ALARM HAS NO POWER. BATTERIES HAVE BEEN REPLACED WITH A NEW SUPPLY ALL OF THE SAME TYPE. NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM. NO PT 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 UNK OVER MATTRESS SENSOR PART #8307, LOT #UNK