BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL BED SYSTEM WITH INDIGO

    MDR report key: 7897006 · Received September 21, 2018

    Report

    Report Number
    3007420694-2018-00184
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 24, 2018
    Report Date
    November 15, 2018
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z O. O.
    Product Code
    FNL
    UDI-DI
    05056097349688
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY 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 MANUFACTURER'S INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#(B)(4) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#(B)(4) ). WE (ARJO) ARE IN PROCESS OF PREPARING FINAL CONCLUSIONS THAT WILL BE PRESENTED IN FINAL REPORT.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY ARJOHUNTLEIGH POLSKA SP. Z O.O. (REGISTRATION#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). ON (B)(6) 2018 ARJO RECEIVED A COMPLAINT INVOLVING CITADEL BED WITH INDIGO SYSTEM (INTENDED TO PROVIDE DRIVING ASSISTANCE FOR MEDICAL BEDS DURING PATIENT TRANSFER). THE REPORTED MALFUNCTION TOOK PLACE IN THE SUEDSTADT KLINIKUM ROSTOCK IN GERMANY. FOLLOWING THE INFORMATION PROVIDED THE ARJO TECHNICIAN CAME TO THE FACILITY IN ORDER TO PICK UP A CITADEL BED FROM THE HOSPITAL AFTER THE RENTAL PERIOD HAD FINISHED. ALTHOUGH THE INDIGO WAS ACTIVATED IT WAS VERY HARD TO MOVE THE BED. WHEN THE TECHNICIAN STOPPED PUSHING THE BED THE DEVICE MOVED BY ITSELF IN THE OPPOSITE DIRECTION. WHILE THE TECHNICIAN WAS LOADING THE BED INTO THE VAN IN ORDER TO TRANSPORT THE DEVICE TO THE SERVICE CENTER HE HEARD A BANG. PROBABLY BECAUSE THE INDIGO WHEEL WAS LOWERED TOUCHING THE WINCH USED FOR TRANSPORTING THE BED INTO THE VAN. WHILE BEING BACK IN SERVICE CENTER THE TECHNICIAN MOVED THE BED INTO THE BUILDING WITH USE OF THE INDIGO. AFTER HE STOPPED PUSHING THE BED THE DEVICE CONTINUED TO MOVE VERY FAST IN THE OPPOSITE DIRECTION. AT THE TIME THE UNINTENDED BED MOVEMENT OCCURRED THERE WAS NO ONE LYING ON THE BED. NO INJURY NOR OTHER MEDICAL CONSEQUENCES WERE REPORTED. DURING BED'S EVALUATION THE TECHNICIAN WAS ABLE TO RECREATE REPORTED MALFUNCTION, THE BED WAS ABLE TO BE STOPPED ONLY USING EMERGENCY STOP. THE VISUAL INSPECTION OF THE BED CONFIRMED THAT THE INDIGO DRIVE UNIT WAS SHIFTED OUT OF CORRECT POSITION, WAS MOVED NEARLY 20 CM TO THE FOOT SIDE OF THE FRAME. ADDITIONALLY THE MIDDLE SECTION OF THE PLATE COVERING DRIVE UNIT WAS BENT (FOUND TO BE 12MM LOWER THAN THE OUTER PARTS OF THE PLATE). A CONSTANT ANGLE OF 2.5 DEGREES WAS ALSO MEASURED ON THE WHEEL ASSEMBLY. DUE TO THE DAMAGE OF THE PLATE, THE INDIGO STARTED SEEING A SLOPE EVEN THOUGH THE SYSTEM WAS POSITIONED ON A FLAT SURFACE. THIS CAUSED THE BED TO CONSTANTLY OVERDRIVE (OR ACCELERATING AS A CONSEQUENCE OF THE OVERDRIVE) ASSUMING THE BED IS GOING UPHILL WHEN ACTUALLY THE BED WAS ON A FLAT SURFACE. THE BED WAS NOT SELF-CONTROLLED DUE TO THE FACT THE ADDITIONAL DRIVE POWER WAS CONFUSING THE CONTROL ALGORITHM. TAKING INTO ACCOUNT ALL THE ABOVE IT CAN BE ASSUMED THAT THE INDIGO BEHAVIOR WITNESSED BY ARJO TECHNICIAN WAS CAUSED BY THE METAL PLATE DEFORMATION - COMPONENT OF THE INDIGO DRIVE ASSIST. THE OCCURRENCE RATE FOR THIS FAILURE MODE WITH THE SAME ROOT CAUSE IS LOW 0,11% (FIRST COMPLAINT). BASED ON ARJO PRODUCT DEVELOPMENT ENGINEER OPINION THIS TYPE OF MALFUNCTION MIGHT BE A RESULT OF EITHER MECHANICAL DAMAGE TO THE INDIGO UNIT OR LACK OF CORRECT SYSTEM CALIBRATION. ALTHOUGH SERVICE TECHNICIAN RESPONSIBLE FOR TRANSPORTING THE BED HEARD A BANG WHILE LOADING THE BED TO THE VAN WE CANNOT ASSUME IT WAS THE CAUSE OF PLATE DEFORMATION DUE TO THE FACT THE INDIGO HAD BEEN WORKING INCORRECTLY EVEN BEFORE DEVICE TRANSPORTATION. WITHOUT HAVING FIRST-LEVEL EVIDENCE WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THE INDIGO COMPONENT PHYSICAL DAMAGE. THE CITADEL PATIENT CARE SYSTEM EQUIPPED WITH INDIGO UNIT (SERIAL NUMBER: P0498419) MANUFACTURED ON JULY 4TH, 2018 WAS CHECKED BEFORE BEING DISTRIBUTED TO THE CUSTOMER AND VERIFIED TO MEET THE REQUIRED MANUFACTURER'S SPECIFICATION. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND NO ANOMALY WAS FOUND THAT WOULD AFFECT INDIGO FUNCTIONALITY. THE PRODUCT INSTRUCTION FOR USE (#416260 REV. B DATED ON FEB 2018) WHICH WAS SUPPLIED TOGETHER WITH THE INVOLVED DEVICE CONTAINS ALL CRUCIAL INFORMATION AND WARNINGS WHICH SHOULD BE FOLLOWED TO ENSURE PATIENT SAFETY: -WEEKLY "CHECK THAT THE INDIGO COVER IS UNDAMAGED" -DAILY "CHECK THAT INDIGO IS ACTIVATED WHEN PEDAL IS IN ITS MOST UPWARD POSITION" -"TO AVOID INJURY, ACTIVATE THE BRAKE ON THE BED AND CALL MAINTENANCE IF UNANTICIPATED MOTION OCCURS" - "TO MINIMIZE THE RISK OF SERIOUS INJURY, CAREFULLY READ AND FOLLOW ALL SAFETY INFORMATION AND OPERATING INSTRUCTIONS BEFORE OPERATING INDIGO. ENSURE ALL PHYSICIAN ORDERS AND FACILITY PROTOCOLS ARE FOLLOWED." ALTHOUGH NO INJURIES WERE REPORTED IN RELATION TO THIS INCIDENT, THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO THE UNCONTROLLED BED MOVEMENT OCCURRENCE AND CAUTIOUS APPROACH. THE DEVICE WAS REPORTED TO MOVE ON ITS OWN AND FROM THAT PERSPECTIVE, THE CITADEL BED EQUIPPED WITH INDIGO DRIVE ASSIST SYSTEM DID NOT MEET MANUFACTURER'S SPECIFICATION.

    Description of Event or Problem · 0

    FOLLOWING THE INFORMATION PROVIDED ARJO SERVICE TECHNICIAN PICKED UP A CITADEL BED FROM HOSPITAL AFTER RENTAL PERIOD. WITH THE ACTIVATED INDIGO THE BED WAS VERY HARD TO MOVE. WHEN THE TECHNICIAN STOPPED PUSHING THE BED, THE DEVICE MOVED BY ITSELF IN THE OPPOSITE DIRECTION. BACK IN THE SERVICE CENTER HE MOVED THE BED INTO THE BUILDING. AFTER HE STOPPED THE PUSHING THE BED MOVED VERY FAST IN THE OPPOSITE DIRECTION. THE BED IS NOW UNDER QUARANTINE. IT NEEDS TO BE EMPHASIZED THAT DURING THE RENTAL TIME THERE WAS NO PROBLEM WITH THE BED NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740245 CITADEL BED SYSTEM WITH INDIGO BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP Z O. O. CXX22C6M4AMFC0 05056097349688

    Patients

    Seq Age Sex Outcome Treatment
    1 Other