BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KEEPSAFE DELUXE

    MDR report key: 8333739 · Received February 12, 2019

    Report

    Report Number
    2020362-2019-00013
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Report Date
    January 18, 2019
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED IN AND ANALYZED. TESTING OF THE UNIT CONFIRMED THE REPORTED ISSUE OF THE ALARM NOT SENDING TO THE NURSE CALL STATION DUE TO A FAULTY NURSE CALL RELAY. BASED ON THE AGE OF THE DEVICE, IT IS LIKELY THE CAUSE FOR THE DEFECT IS NORMAL WEAR AND TEAR. AT THIS TIME, THERE IS NO EVIDENCE THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT AND THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNING FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THE IFU STATES, TO REDUCE THE RISK OF SERIOUS INJURY OR DEATH, TEST THE ALARM AND SENSOR FOR PROPER OPERATION PRIOR TO PUTTING IN SERVICE WITH A PATIENT, AND EACH TIME BEFORE LEAVING THE PATIENT 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, SENSOR OR MAGNET IF IT DOES NOT ACTIVATE EACH TIME WEIGHT IS REMOVED FROM THE SENSOR, THE CHAIR BELT SENSOR IS UNFASTENED, OR MAGNET IS REMOVED FROM FACE PLATE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED AND ACTED UPON AS WARRANT. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE ALARM WILL NOT SOUND WHEN USING THE NURSE CALL CABLE. THE ALARM DOES SOUND WHEN PATIENT GETS UP FROM SENSOR BUT IS NOT PLUGGED INTO THE NURSE CALL CABLE. THE DATE THE ISSUE WAS DISCOVERED IS UNKNOWN AND NO PATIENT INCIDENT OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123856 KEEPSAFE DELUXE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8374

    Patients

    Seq Age Sex Outcome Treatment
    1