BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL PLUS

    MDR report key: 7258581 · Received February 9, 2018

    Report

    Report Number
    3007420694-2018-00042
    Event Type
    Malfunction
    Date Received
    February 9, 2018
    Report Date
    May 8, 2018
    Manufacturer
    ARJOHUNTLEIGH POLSKA
    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 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 (B)(4). EACH CITADEL PLUS BED IS EQUIPPED WITH POWER DRIVE SYSTEM DESIGNED TO PROVIDE POWERED TRANSPORT FOR THE CITADEL PLUS BARIATRIC BED FRAME SYSTEM. THIS POWER DRIVE SYSTEM FEATURE IS RESPONSIBLE FOR ACTIVATING FORWARD AND BACKWARD MOVEMENT OF THE DEVICE. LEFT AND RIGHT HAND STEERING ARE CONTROLLED BY THE USER, HAVE TO BE APPLIED AT THE SAME TIME. LEFT HAND TRIGGER MUST BE HELD DOWN DURING ENTIRE DURATION OF POWER DRIVE OPERATION. RIGHT HAND TRIGGER IS USED TO GIVE DIRECTION TO MOVEMENT (FORWARD OR BACKWARDS). RELEASING LEFT HAND TRIGGER WILL APPLY THE POWER DRIVE BRAKE AND MAKE THE POWER DRIVE INOPERABLE. ON 2018-JAN-12 ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT INVOLVING CITADEL PLUS BED. FOLLOWING THE INFORMATION REPORTED AFTER RELEASING BOTH POWER RIVE HANDLES THE BED CONTINUED TO MOVE FORWARD SEVERAL FEET VERY RAPIDLY. THE BED IN QUESTION WAS A PART OF RENTAL FLEET. THE MALFUNCTION WAS FOUND BY ARJOHUNTLEIGH TECHNICIAN DURING QUALITY CHECK AFTER RENTAL PERIOD. THERE WAS NO CUSTOMER ALLEGING THIS DEFECT, NO INJURY NOR OTHER MEDICAL CONSEQUENCES WERE REPORTED. THE ROOT CAUSE INVESTIGATION WAS PERFORMED WITH COOPERATION WITH ARJOHUNTLEIGH TECHNICIAN AND INNOVATION CENTER. ACCORDING TO THE INFORMATION PROVIDED BY ARJOHUNTLEIGH TECHNICIAN WE ESTABLISHED THAT THE MALFUNCTION WAS DISCOVERED WHILE MOVING THE BED ON THE FLAT FLOOR. THE POWER DRIVE JOYSTICK (RIGHT POWER DRIVE HANDLE) WAS NOT STUCK IN FORWARD POSITION. THERE WAS NO VISIBLE SIGNS OF MISUSE ON THAT BED. THE ISSUE WAS SOLVED BY TECHNICIAN THROUGHOUT PERFORMING DEVICE RESET. THE BED WAS UNPLUGGED, ALL CABLES WERE DISCONNECTED FROM THE CHARGER BOARD AND RESIDUAL POWER WAS DRAINED BY PULLING LEFT HAND TRIGGER. THEN ALL CABLES WERE RECONNECTED. THE BED HAD A METAL COVER OVER POWER DRIVE BOX IN PLACE AT THE TIME OF INSPECTION. HOWEVER IT REMIND UNKNOWN IF THE METAL COVER WAS UNINTENTIONALLY PRESSING RESET BUTTON ON THE PCBA POTENTIALLY CAUSING THE INCIDENT. IT NEEDS TO BE EMPHASIZED THAT PRESSING THE RESET BUTTON COULD PUT THE POWER DRIVE IN A DIFFERENT MODE THAN THE NORMAL OPERATION. THE TECHNICIAN WAS ABLE TO RECREATE THE MALFUNCTION BEFORE RESETTING THE BED, AFTER THE DEVICE RESET THE BED STARTED WORKING AS INTENDED. UNFORTUNATELY DUE TO LACK OF BED BEING AVAILABLE FOR FURTHER INSPECTION (BED WAS RETURNED TO THE RENTAL FLEET) AND INSUFFICIENT INFORMATION PROVIDED WITHIN THE COMPLAINT WE ARE NOT IN POSITION TO DETERMINE THE EXACT CAUSE OF THE ISSUE OCCURRENCE. ALTHOUGH NO INJURIES WERE REPORTED IN RELATION TO THIS MALFUNCTION, THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO THE BED'S DELAY IN STOPPING. THERE WAS NO INDICATION OF PATIENT'S INVOLVEMENT. AT THE TIME THE INCIDENT OCCURRED ARJOHUNTLEIGH DEVICES FAILED TO MEET MANUFACTURER'S SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    MISSING UDI NUMBER WAS ADDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED UNDER EXEMPTION E2012070 BY (B)(4). UPDATE: FROM THE DESIGN PERSPECTIVE ACCORDING TO THE PERFORMANCE TEST, THE STOPPING DISTANCE FOR POWER DRIVE IS 5 FEET FROM FULL SPEED ONCE THE LEFT HAND TRIGGER IS RELEASED. THE BED CANNOT BE STOPPED IMMEDIATELY AFTER RELEASING POWER DRIVE HANDLE TO PROVIDE SMOOTH, SAFETY OPERATION OF THE DEVICE, IN A WAY TO AVOID SUDDEN STOPS. THE ABOVE CONFIRMS THAT CLAIMED BED OPERATED AS INTENDED (THE CUSTOMER ALLEGATION WAS THAT AFTER RELEASING POWER DRIVE HANDLES THE BED CONTINUED TO MOVE SEVERAL FEET FORWARD). IN A LIGHT OF PERFORMANCE TEST THE POWER DRIVE STOPPING WITHIN 5 FEET AFTER RELEASING LEFT POWER DRIVE HANDLE IS UP TO MANUFACTURER SPECIFICATION THEREFORE WE NO LONGER SEE SUCH A SCENARIO TO BE REPORTABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2018 ARJOHUNTLEIGH WAS INFORMED ABOUT AN INCIDENT INVOLVING CITADEL PLUS BED. FOLLOWING THE INFORMATION PROVIDED THE BED WAS MOVING SEVERAL FEETS FORWARD AFTER RELEASING BOTH POWER DRIVE HANDLES. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103643 CITADEL PLUS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA FX811B3B4AMABB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other