BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SITTER ELITE

    MDR report key: 7844045 · Received September 4, 2018

    Report

    Report Number
    2020362-2018-00110
    Event Type
    Malfunction
    Date Received
    September 4, 2018
    Report Date
    August 10, 2018
    Manufacturer
    POSEY PRODUCTS LLC
    Product Code
    PJO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF THE RETURNED UNIT CONFIRMED THE REPORTED ISSUE OF THE ALARM NOT SENDING A SIGNAL TO THE NURSE CALL STATION DUE TO A FAULTY NURSE CALL RELAY. ROOT CAUSE FOR THE FAILURE COULD NOT BE DETERMINED. HOWEVER, DUE TO THE PRODUCT BEING OVER A YEAR OLD, IT'S POSSIBLE WEAR AND TEAR CONTRIBUTED TO THE FAILURE. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE PASSED ALL PRODUCT VERIFICATION TESTING AND MET SPECIFICATIONS PRIOR TO BEING SHIPPED. 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 IS NOT SENDING A SIGNAL TO THE NURSE'S STATION. CUSTOMER TRIED ANOTHER CABLE BUT PROBLEM PERSISTED. CUSTOMER CONFIRMED THE CABLE CONNECTED SECURELY AND THERE WERE NO NOTICEABLE DAMAGES TO THE NURSE CALL RECEPTACLE. 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
    685249 SITTER ELITE FALL PREVENTION ALARM/SENSOR COMBINATION ATTACHED OR UNATTACHED PJO POSEY PRODUCTS LLC 8345

    Patients

    Seq Age Sex Outcome Treatment
    1