BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CITADEL PLUS

    MDR report key: 10256947 · Received July 10, 2020

    Report

    Report Number
    3007420694-2020-00114
    Event Type
    Injury
    Date Received
    July 10, 2020
    Date of Event
    June 17, 2020
    Report Date
    July 16, 2020
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    UDI-DI
    05055982756532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AN INSTALLATION OF A BED AT ARJO RENTAL SERVICE CENTRE, IT WAS FOUND THAT THE BED DID NOT WORK. BURNED MAIN JUNCTION BOX AND CABLES CONNECTED TO IT FOUND AFTER TROUBLESHOOTING. NO PATIENT WAS INVOLVED. NO INJURY OCCURRED. ON 2020-JUL-01, THE SAME SYMPTOM FAILURE HAS BEEN RECREATED AND ACKNOWLEDGED BY THE MANUFACTURER. IT WAS ESTABLISHED THAT THE ROOT CAUSE OF REPORTED ISSUE IS A COMBINATION OF TWO ERRORS OCCURRING ON THE BED AT THE SAME TIME: 1. CLAMP CABLE INSULATION TEARING WITHIN ELECTRONIC BAY BOX DUE TO EXCESSIVE VIBRATIONS, AND 2. QLCI GROUNDING SCREW TOUCHING THE METAL SUPPORT. IN RESULT, THERE IS A LIKELIHOOD, THE MAIN JUNCTION BOX (MJB) AND CABLES CONNECTED TO IT CAN MELT EMITTING AN UNPLEASANT SMELL (EACH CITADEL PLUS BED IS EQUIPPED WITH MJB, SITUATED BENEATH THE MATTRESS PLATFORM IN THE MIDDLE OF THE BED, ALLOWING TO CONNECT REMOTE CONTROLS, CONTROL PANELS OR OTHER ACCESSORIES.). AS A CONSEQUENCE OF THIS PROBLEM, THE FUNCTIONALITY OF THE BED CAN BE DISTURBED, MEANING THAT ELECTRICAL FUNCTIONS MAY NOT BE RESPONDING TO ANY COMMANDS GIVEN, AND BED IS ¿FROZEN¿. FOLLOWING A TECHNICAL EVALUATION, IT WAS CONCLUDED THAT EVEN IF THE FAILURE OCCURS, THERE IS NO POSSIBILITY OF DEVICE IGNITION (SINCE THE COMPONENTS ARE MADE OF FIRE RETARDANT MATERIALS), NOR HEAT TRANSMISSION TO THE MATTRESS. HOWEVER, ALTHOUGH THE PROBABILITY OF OCCURRENCE OF HARM IS VERY LIMITED, OUR INVESTIGATION REVEALS, THAT THERE IS A POTENTIAL FOR CURRENT LEAKAGE WHICH CAN RESULT IN ELECTRIC SHOCK, IN CASE PATIENT WOULD TOUCH SKIN IQ METAL CABLE CONNECTOR (SITUATED AT THE FOOT END OF THE BED) AND METAL BED FRAME AT THE SAME TIME. A CAPA (CORRECTIVE AND PREVENTIVE ACTION) HAS BEEN COMMENCED IN ORDER TO ADDRESS THE ISSUE AND PREVENT IT FROM REOCCURRING. ACTIONS UNDERTAKEN IN THE COURSE OF THE CAPA ENSURE THAT NEWLY MANUFACTURED DEVICES WILL BE FREE OF THE RECOGNIZED FAILURE MODE AND THE AFFECTED DEVICES WILL BE REWORKED (CORRECTED) EFFECTIVELY. ON 2020-JUL-13, THE FIELD SAFETY CORRECTIVE ACTION (FSCA, INTERNAL NUMBER FCN-POZ-001-2020) HAS BEEN COMMENCED TO ALL ARJO CUSTOMERS OWNING THE CITADEL PLUS BED MANUFACTURED BETWEEN 2020-APR-17 AND 2020-JUN-30. TO CONCLUDE, ARJO ACKNOWLEDGED THAT THE MALFUNCTION RESULTED IN MELTING MAIN JUNCTION BOX UNDER VERY SPECIFIC CONDITIONS THAT NEED TO HAPPEN AT THE SAME TIME, WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, IF THE MALFUNCTION WERE TO RECUR THEREFORE THIS COMPLAINT WAS DECIDED TO BE REPORTABLE TO COMPETENT AUTHORITY, ALTHOUGH NO PATIENT WAS INVOLVED AND NO INJURY OCCURRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION WILL BE PROVIDED TO THE FOLLOW UP REPORT.

    Description of Event or Problem · 1

    DURING AN INSTALLATION OF A BED AT ARJO RENTAL SERVICE CENTER, IT WAS FOUND THAT THE BED DID NOT WORK, FLASHING E410 ERROR CODE. BURNED MAIN JUNCTION BOX AND CABLES CONNECTED TO IT FOUND AFTER TROUBLESHOOTING. NO PATIENT WAS INVOLVED. NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722471 CITADEL PLUS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. FX811B3B4AMABB 05055982756532

    Patients

    Seq Age Sex Outcome Treatment
    1 Other