BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL PATIENT CARE SYSTEM

    MDR report key: 6078721 · Received November 4, 2016

    Report

    Report Number
    3007420694-2016-00229
    Event Type
    Malfunction
    Date Received
    November 4, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z O.O
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY THE MANUFACTURER ARJOHUNTLEIGH POLSKA SP. Z O. O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION #1419652). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY THE MANUFACTURER ARJOHUNTLEIGH POLSKA SP. Z O. O. (REGISTRATION #3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION #1419652). ON 2016-OCT-08 ARJOHUNTLEIGH RECEIVED THE FOLLOWING COMPLAINT ON THE BACKREST IS GOING DOWN SLOWLY WITH WEIGHT APPLIED ON BACKREST. IN THE RESULT OF THIS - ACTUATOR WAS EXCHANGED. LATER ON THE TESTS CONFIRMED THAT THE BED WAS OPERATIONAL ACCORDING TO THE DESIGN SPECIFICATION. TO ARJOHUNTLEIGH'S BEST KNOWLEDGE NO PATIENT WAS NOT INVOLVED IN ANY INCIDENT. A REVIEW OF STANDARD AND REPORTABLE COMPLAINTS WAS PERFORMED SHOWING THERE IS NO TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE FOR CITADEL BED FOR THESE KINDS OF EVENTS. THE DEVICE DID FAIL TO MEET ITS SPECIFICATIONS SINCE THE BED WAS WORKING WITHOUT ANY COMMANDS BEING GIVEN. DEVICE HISTORY REVIEW DID NOT SHOW ANY DISCREPANCIES THAT COULD LEAD TO SUCH CONDITION. IT SEEMS THAT THE UNINTENDED BACKREST MOVEMENT OCCURS WHEN THERE IS WEIGHT APPLIED ON THE BACKREST USUALLY IN EITHER OF TWO CONFIGURATIONS: WHEN THE CPR CABLE IS TO TIGHTLY ADJUSTED. WHEN THE BACKREST ACTUATOR WOULD NOT HOLD THE WEIGHT. IN THIS OCCASION, THE BED WAS INSPECTED BY THE SERVICE TECHNICIAN AND THE BACKREST ACTUATOR WAS FOUND TO BE FAULTY AND LATER ON REPLACED BY THE SERVICE TECHNICIAN. TESTS PERFORMED AFTER THE REPLACEMENT CONFIRMED THAT THE BED WAS OPERATING AS INTENDED. IN SUMMARY, GIVEN THE CIRCUMSTANCES THIS INCIDENT APPEARS TO BE A RARELY OCCURRING ISSUE. ON OUR DEVICE - CITADEL BED - THE BACKREST LOWERED WITHOUT ANY COMMANDS BEING GIVEN THEREFORE THIS EVENT IS CONSIDERED TO BE A DEVICE TECHNICAL MALFUNCTION DUE TO THE BACKREST THAT COULD NOT HOLD THE BACKREST WITH ADDITIONAL WEIGHT. DESPITE THE FACT THAT THE DEVICE WAS NOT IN USE WITH PATIENT DURING THE EVENT AND NO INJURIES WERE REPORTED, THE COMPLAINT WILL BE REPORTABLE DUE TO THE POSSIBLE RISK TO THE PATIENTS HEALTH IF THE FAILURE WAS TO REOCCUR.

    Description of Event or Problem · 0

    ON 2016-OCT-08 ARJOHUNTLEIGH RECEIVED THE FOLLOWING COMPLAINT ON THE BACKREST IS GOING DOWN SLOWLY WITH WEIGHT APPLIED ON BACKREST. IN THE RESULT OF THIS - ACUATOR WAS EXCHANGED. LATER ON THE TESTS CONFIRMED THAT THE BED WAS OPERATIONAL ACCORDINGLY TO THE SPECIFICATION. TO ARJOHUNTLEIGH BEST KNOWLEDGE THE PATIENT WAS NOT INVOLVED IN THE AFOREMENTIONED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731143 CITADEL PATIENT CARE SYSTEM CITADEL BED FRAME SYSTEM FNL ARJOHUNTLEIGH POLSKA SP Z O.O CX721B6R4AMBA0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other