BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2974758 · Received January 18, 2013

    Report

    Report Number
    2020362-2013-06020
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Report Date
    December 19, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - EVAL OF THE RETURNED PRODUCT DOES NOT CONFIRM THE REPORTED ISSUE; THE ALARM POWERED ON WHEN BATTERIES WERE INSTALLED ON ALL THREE ATTEMPTS AND NO INTERMITTENCY WAS OBSERVED. THE VOICE MESSAGE PLAYS WITH STATIC BUT THE TONE SELECTION PLAYS CLEARLY. THE ALARM IS MISSING THE BATTERY DOOR AND THERE IS EVIDENCE OF BATTERY ACID ON THE BATTERY CONTACTS AND SPRINGS. ONE OF THE FOUR SCREWS THAT HOLD THE ALARM CASE TOGETHER IS MISSING. THE ALARM CASE IS NOT CLOSED FLUSH. THE POWER SWITCH IS PUSHED INTO THE CASE. AQUALERT MOISTURE INDICATOR LABEL SHOWS EXPOSURE TO MOISTURE. THE HOLD/SUSPEND BUTTON IS MISSING. NOTE: POSEY INSTRUCTIONS FOR USE HAS A STATEMENT: IF THE POSEY KEEP SAFE DELUXE 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 THE POSEY KEEP SAFE DELUXE IF THE AUDIBLE ALARM DOES NOT SOUND. 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 SENT 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. STORE THE ALARM IN A SECURE PLACE SO IT WILL NOT BE DROPPED OR DAMAGED. DO NOT USE IF; BATTERY DOOR IS MISSING; BATTERY DOOR IS DAMAGED; ALARM CASE IS DAMAGED; OR ALARM CASE. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM WILL NOT POWER ON AFTER THEY REPLACED THE BATTERIES WITH NEW ONES. THERE ARE NO SIGNS OF BATTERY LEAKAGE OR CORROSION ON THE BATTERY SPRINGS AND THE BATTERY SPRINGS ARE NOT BENT. THE CUSTOMER DID NOT PROVIDE THE DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28775 POSEY KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

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