BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 3100009 · Received April 26, 2013

    Report

    Report Number
    2020362-2013-00194
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Report Date
    April 3, 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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVALUATION OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE; WHEN SET TO VOICE MODE, THE VOICE PLAYS ONLY ONCE AND NOT CONTINUOUSLY AS IT SHOULD. WHEN SET TO VOICE AND TONE, THE VOICE MESSAGE ONLY PLAYS ONCE AND NO TONE SOUNDS AS IT SHOULD. THE SOUND COMING FROM THE SPEAKER SOUNDS SCRATCHY. HOLD/SUSPEND BUTTON IS MISSING, BATTERY DOOR IS MISSING, LED LENS IS PUSHED INTO THE CASE AND A BATTERY SPRING IS BENT. NOTE: POSEY INSTRUCTIONS FOR USE HAS A STATEMENT: IF THE POSEY KEEPSAFE 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 IF THE AUDIBLE ALARM DOES NOT SOUND. TAKE CARE WHEN INSTALLING NEW BATTERIES. TAKE CARE NOT TO DAMAGE BATTERY CONTACTS. DO NOT MIX OLD AND NEW BATTERIES, OR BATTERY BRANDS WITHIN A BATTERY PACK (4 BATTERIES). USE OF MIXED 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 WHEN THE VOICE AND TONE OPTION IS IN USE THE ALARM SOUNDS ONLY ONCE AND THE ALARM DOES NOT SOUND CONTINUOUSLY. THE CUSTOMER DID NOT PROVIDE THE DATE WHEN THIS WAS FOUND. NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181834 KEEPSAFE DELUXE KMI J. T. POSEY CO. 8374 NA

    Patients

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