BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 2914829 · Received December 7, 2012

    Report

    Report Number
    2020362-2012-00669
    Event Type
    Malfunction
    Date Received
    December 7, 2012
    Report Date
    November 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
    WI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: EVAL OF THE RETURNED PRODUCT DID NOT CONFIRM THE REPORTED ISSUE. NURSE CALL LIGHT DID NOT REMAIN CONTINUOUSLY ON. UNIT POWERS UP AND NURSE CALL LIGHT COMES ON WHEN IT SHOULD BUT TURNS OFF INTERMITTENTLY WHEN NURSE CALL CABLE IS WIGGLED WHEN USING A KNOWN WORKING NURSE CALL TEST FIXTURE AND NURSE CALL CABLE. VOICE MESSAGE PLAYS BUT WITH STATIC. THE WARNING LABEL IS TORN ACROSS THE MIDDLE AND THE LED LENS SITS UNEVENLY. THE CUSTOMER DID NOT RETURN THE NURSE CALL CABLE USED WITH THIS ALARM. NOTE: THE INSTRUCTIONS FOR USE HAS A WARNING STATEMENT: THE ALARM IS AN ELECTRONIC DEVICE. IT MAY FAIL TO WORK IF SUBJECTED TO SEVERE SHOCK, SUCH AS BEING DROPPED, OR IMMERSED IN LIQUID. TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PT, AND EACH TIME BEFORE LEAVING THE PT UNATTENDED. IF THE ALARM AND/OR SENSOR DO NOT FUNCTION PROPERLY, REMOVE THE ALARM AND SENSOR FROM SERVICE AND REPLACE THEM WITH A PROPERLY FUNCTIONING ALARM AND/OR SENSOR. DO NOT USE THE ALARM OR SENSOR IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED, OR THE PIR SENSOR IS ACTIVATED. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE ALARM SOUNDS CONTINUOUSLY AT THE NURSE CALL STATION WHICH WAS DISCOVERED WHILE IN USE. THE CUSTOMER REPORTED THEY ARE USING THE NURSE CALL CABLE PROVIDED BY POSEY. THE CUSTOMER DID NOT PROVIDE A SPECIFIC DATE WHEN THIS WAS FOUND. THERE WAS NO PT INCIDENT OR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK NURSE CALL CABLE, MODEL 8282, LOT #NA