BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POSEY KEEPSAFE DELUXE

    MDR report key: 2974724 · Received January 18, 2013

    Report

    Report Number
    2020362-2013-00023
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Report Date
    December 26, 2012
    Manufacturer
    J. T. POSEY CO.
    Product Code
    KMI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED PRODUCT CONFIRMED THE REPORTED ISSUE. UNIT HAS INTERMITTENT POWER WHEN USING BATTERIES. BATTERIES HAD TO BE MOVED IN ORDER TO POWER THE UNIT AND IF MOVED TO A CERTAIN DIRECTION THE UNIT WILL POWER OFF. UNIT POWERS UP AND STAYS ON WHEN USING A 9V ADAPTER OR AN EXTERNAL POWER SUPPLY. UNIT PASSES ALL FUNCTIONAL TESTS. BATTERY DOOR IS MISSING. BATTERY SPRINGS ARE BENT. RJ-11 PINS IN THE ALARM RECEPTACLE ARE CORRODED. NOTE: POSEY INSTRUCTION FOR USE HAS A STATEMENT: PROPER HANDLING AND USE: 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 THE POSEY KEEPSAFE DELUXE IF THE AUDIBLE ALARM DOES NOT SOUND. TAKE CARE WHEN INSTALLING NEW BATTERIES. THE ALARM WILL NOT WORK IF BATTERIES ARE INSTALLED IMPROPERLY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM SOUND INTERMITTENTLY. THE BATTERIES HAVE BEEN REPLACED WITH NEW ONES. THE CUSTOMER TESTED THE ALARM WITH A NEW SENSOR AND THE RESULTS REMAIN THE SAME. THERE IS NO VISIBLE DAMAGE TO THE OUTSIDE OF THE ALARM REPORTED. THE CUSTOMER DID NOT PROVIDE A DATE WHEN THIS WAS DISCOVERED. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28766 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