BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2982837 · Received January 31, 2013

    Report

    Report Number
    2020362-2013-00037
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Report Date
    January 8, 2013
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE; THE ALARM DID NOT POWER UP WHEN USING CUSTOMER'S BATTERIES OR NEW BATTERIES. THE ALARM POWERS UP WHEN USING AN EXTERNAL POWER SUPPLY OR 9V ADAPTER HOWEVER; THERE IS BATTERY LEAKAGE RESIDUE ON THE FLAT CONTACTS AND INSIDE THE BATTERY COMPARTMENT. AQUALERT WATER INDICATOR LABEL SHOWS MOISTURE EXPOSURE. NOTE: POSEY INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: IF THE ALARM IS SUBJECTED TO SEVERE MECHANICAL SHOCK, SUCH AS DROPPING, OR IS SUBMERGED IN LIQUID, IT MAY STOP FUNCTIONING AS DESIGNED. VISUALLY INSPECT THE UNIT FOR CRACKS IN THE CASE, MISSING SCREWS, MISSING BATTERY DOOR, BROKEN WIRES OR SIGNS OF EXPOSURE TO LIQUID. AFTER EACH INCIDENT, YOU MUST VERIFY THAT THE UNIT IS WORKING PROPERLY. CHECK TO MAKE SURE THE AUDIBLE ALARM IS FUNCTIONING PROPERLY BY APPLYING AND LIFTING WEIGHT OFF SENSOR IN SEVERAL SPOTS TO ACTIVATE THE ALARM. DO NOT USE IF THE AUDIBLE ALARM DOES NOT SOUND. TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. ALWAYS INSTALLED A COMPLETELY NEW SET OF BATTERIES WHEN THE CHIRPING DUE TO LOW BATTERIES 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

    CUSTOMER REPORTED UNIT WILL NOT POWER ON. THE CUSTOMER REPORTED THE BATTERIES WERE REPLACED WITH A NEW SUPPLY, NO SIGNS OF BATTERY CORROSION OR LEAKAGE IN THE BATTERY COMPARTMENT AND THE BATTERY SPRINGS ARE NOT BENT. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41927 POSEY KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OVER-THE-MATTRESS SENSOR PAD MODEL: 8307, LOT #UNK