BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL PLUS

    MDR report key: 7340770 · Received March 15, 2018

    Report

    Report Number
    3007420694-2018-00064
    Event Type
    Malfunction
    Date Received
    March 15, 2018
    Report Date
    May 8, 2018
    Manufacturer
    ARJOHUNTLEIGH POLSKA
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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#3007420694) ON BEHALF OF THE IMPORTER ARJOHUNTLEIGH, INC. (AHUS) (REGISTRATION#1419652). 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-FE-15 ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT INVOLVING CITADEL PLUS BED. FOLLOWING THE INFORMATION REPORTED THE BED WAS MOVING WITH ONLY ONE POWER DRIVE HANDLE BEING ENGAGED (LEFT HANDLE), AFTER RELEASING THE HANDLE THE BED CONTINUED TO MOVE FORWARD ABOUT 4 FEET. THE DEVICE 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 SUCH A DEFECT, NO INJURY NOR OTHER MEDICAL CONSEQUENCES WERE REPORTED. ACCORDING TO THE ADDITIONAL INFORMATION PROVIDED BY ARJOHUNTLEIGH TECHNICIAN WE ESTABLISHED THAT THE MALFUNCTION WAS DISCOVERED WHILE MOVING THE BED ON THE FLAT FLOOR. THE ISSUE WAS SOLVED BY TECHNICIAN THROUGHOUT REPLACING LEFT POWER DRIVE HANDLE. THERE WAS NO POWER DRIVE RESET PERFORMED. BEFORE CHANGING LEFT POWER DRIVE HANDLE IT WAS POSSIBLE THE RECREATE REPORTED MALFUNCTION, AFTER CHANGING THE PART THE BED STARTED WORKING AS INTENDED, ACCORDING TO THE MANUFACTURER'S SPECIFICATION. THE METAL ENCLOSURE OF THE POWER DRIVE PCBA LOOKED BRAND NEW. ACCORDING TO THE SERVICE TECHNICIAN IT WAS NOT POSSIBLE THAT THE POWER DRIVE RESET BUTTON WAS UNINTENTIONALLY PRESSED BY METAL COVER LEADING TO THE ISSUE OCCURRENCE. UNFORTUNATELY DUE TO LACK OF PART BEING AVAILABLE FOR FURTHER INSPECTION WE WERE 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 THE MOVEMENT. THERE WAS NO INDICATION OF PATIENT'S INVOLVEMENT. AT THE TIME THE INCIDENT OCCURRED ARJOHUNTLEIGH DEVICES FAILED TO MEET MANUFACTURER'S SPECIFICATIONS. ARJOHUNTLEIGH WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE AND WILL TAKE THE NECESSARY ACTIONS, IF NEEDED.

    Additional Manufacturer Narrative · 0

    THE 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 LEFT POWER DRIVE HANDLE THE BED CONTINUED TO MOVE 4 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 NOTIFIED ABOUT THE COMPLAINT INVOLVING CITADEL PLUS BED. FOLLOWING INFORMATION PROVIDED THE BED WAS MOVING WITH ONLY ONE POWER DRIVE HANDLE (LEFT ONE) BEING ENGAGED. AFTER RELEASING THE HANDLE THE BED WAS MOVING BY ITSELF ABOUT 4 FEET. THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184223 CITADEL PLUS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA FX811B3B4AMABB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other