BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE FALL MONITOR

    MDR report key: 3180129 · Received June 4, 2013

    Report

    Report Number
    2020362-2013-00241
    Event Type
    Malfunction
    Date Received
    June 4, 2013
    Report Date
    May 9, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED UNIT CONFIRMED THE REPORTED ISSUE. UNIT HAS POWER BUT ALARM DOES NOT SOUND WHEN WEIGHT IS REMOVED FROM SENSOR. THE FAIL SAFE FEATURE DOES NOT WORK AND THE BATTERY DOOR IS MISSING. NOTE: INSTRUCTIONS FOR USE STATE: IF THE POSEY KEEPSAFE 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 MUSH VERIFY THAT THE UNIT IS WORKING PROPERLY. TURN ALARM UNIT ON AND VERIFY GREEN LIGHT BLINKS. VERIFY BATTERIES ARE FRESH. IF YOU HEAR AN INTERMITTENT "CHIRP", THE BATTERY IS LOW AND NEEDS TO BE CHANGED. CHECK TO MAKE SURE THE AUDIBLE ALARM IS FUNCTIONING PROPERLY BY APPLYING AND LIFTING WEIGHT OFF SENSOR IN SEVERAL SPOTS TO ACHIEVE THE ALARM. DO NOT USE THE POSEY KEEPSAFE IF THE AUDIBLE ALARM DOES NOT SOUND. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THE PT'S WEIGHT IS LIFTED FROM THE SENSOR, THE ALARM DOES NOT SOUND. CUSTOMER TESTED THE SENSOR WITH A KNOWN WORKING ALARM AND THE SENSOR FUNCTIONS PROPERLY. CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. NO PT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247631 KEEPSAFE FALL MONITOR KMI J. T. POSEY CO. 8350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK OVER MATTRESS SENSOR: PART #8307, LOT # UNK