BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CITADEL PLUS

    MDR report key: 8212156 · Received January 3, 2019

    Report

    Report Number
    3007420694-2019-00002
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Report Date
    January 3, 2019
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z O. O.
    Product Code
    FNL
    UDI-DI
    05055982756532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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). ON 2018-DEC-04 ARJO WAS NOTIFIED ABOUT THE CITADEL PLUS BED MALFUNCTION. UPON TECHNICIAN'S ARRIVAL TO THE CUSTOMER IT WAS DISCOVERED THAT THE PATIENT LOWER LEFT SAFETY SIDE WAS ON, BUT FALLING OFF THE HINGE. PATIENT WAS MOVED FROM THIS BED TO ANOTHER BED FOR SAFETY CONCERNS. THERE WAS NO INJURY NOR OTHER MEDICAL CONSEQUENCES REPORTED. THE DEVICE WAS TAKEN TO THE SERVICE CENTER FOR A REPAIR. UPON THE DEVICE EVALUATION, ARJO SERVICE TECHNICIAN CONFIRMED THAT THE PLASTIC PART OF THE SAFETY SIDE SEPARATED FROM THE SAFETY SIDE ASSEMBLY. THE SAFETY SIDE PANEL WAS SEVERELY DAMAGED WITH SIGNS OF ENORMOUS FORCE BEING APPLIED INTO THE PANEL. AS PER ARJO TECHNICIAN THE SAFETY SIDE BECAME DAMAGED WHEN MOVED FROM DOWN TO UP POSITION. IT CAN HAPPEN WHILE THE WIDTH EXTENSION FRAME IS NOT EXPANDED EVENLY (ONLY HEAD END SECTION EXPANDED) AND THE BACKREST IS RAISED. SUCH A SEQUENCE OF EVENTS MAY LEAD TO THE SITUATION IN WHICH THE EXPENDED FRAME CONTACTS THE FOOT END SIDE RAIL BENDING IT. TO ENSURE THE SAFETY OF OUR PRODUCTS THE INSTRUCTION FOR USE PROVIDED TOGETHER WITH THE INVOLVED DEVICE (831-374 REV. B DATED ON DEC 2015) INCLUDES WARNING REGARDING THE NEED OF EXTENDING ALL WIDTH EXTENSION FRAME SECTIONS: "MAKE SURE ALL EIGHT WIDTH EXTENSION SECTIONS ARE EXTENDED. USING THE BED WITHOUT ALL EXTENSION IN THE SAME POSITION MAY CAUSE DAMAGE TO THE BED AS WELL AS CREATE AN UNSAFE CONDITION." ADDITIONALLY IT NEEDS TO BE EMPHASIZED THAT THE SAFETY SIDES ARE NOT INTENDED FOR MANEUVERING THE BED NOR FOR BEING USED AS A SUPORT LEVER. A REPEATED ACTIVITIES AS SUCH COULD HAVE WEAKENED SAFETY SIDE MATERIAL WHAT IN CONSEQUENCE CONTRIBUTED TO THE SAFETY SIDE DETACHMENT. THAT CITADEL PLUS BARIATRIC CARE SYSTEM MEETS THE REQUIREMENTS OF STANDARD IEC 60601-2-52 FOR MEDICAL DEVICES, ACCORDING TO WHICH: "SIDE RAIL LATCHED/LOCKS SHALL REMAIN SECURE WHEN SUBJECTED TO THE FORCES OF NORMAL USE" "SIDE RAIL SHALL BE DESIGNED TO WITHSTAND THE FORCES APPLIED DURING REASONABLY FORESEEABLE MISUSE OVER THE PRODUCT LIFE CYCLE WITHOUT CREATING AN UNACCEPTABLE RISK. COMPLIANCE IT CHECKED BY THE FOLLOWING TEST WITH THE SIDE RAIL IN UPPER POSITION: A) LATERAL FORCE CYCLING TEST. EXERT A FORCE OF 100 N THAT IS PERPENDICULAR TO THE SIDE RAIL AT THE TOP MIDDLE SECTION OF THE SIDE RAIL, REPEAT FOR 3 000 CYCLES. B) LONGITUDINAL FORCE CYCLING TEST. EXERT A FORCE OF 100 N ON THE SIDE RAIL IN THE LENGTHWISE DIRECTION OF THE SIDE RAIL, REPEAT FOR 3 000 CYCLES. C) VERTICAL FORCE CYCLING TEST. EXERT A FORCE OF 100 N ON THE UPPERMOST PART OF THE SIDE RAIL IN THE VERTICAL DIRECTION OF THE SIDE RAIL, REPEAT FOR 3 000 CYCLES. UPON COMPLETION A), B) AND C) ABOVE, APPLY A STATIC LOAD IN THE DIRECTIONS IN WORST CASE POSITIONS. MOREOVER THE STANDARD REQUIRES TO VERIFY SIDE RAIL STRENGTH AND LATCH RELIABILITY EXERTING A FORCE OF 750N ON THE UPPERMOST PART OF THE SIDE RAIL IN THE VERTICAL DIRECTION OF THE SIDE RAIL. A DURABILITY OF THE PANEL AGAINST LATERAL FORCES IS CHECKED BY APPLYING 500N TO THE SAFETY SIDE. WHAT IS MORE, IFU INDICATES THE MINIMUM RECOMMENDED LEVEL OF PREVENTIVE MAINTENANCE. CHECK OPERATION OF SIDE RAILS SHOULD BE COMPLETED BY CAREGIVER EVERY DAY. THE PROCEDURE MUST BE CARRIED OUT BY SUITABLY TRAINED AND QUALIFIED PERSONNEL. TAKING INTO ACCOUNT ALL ABOVE IT CAN BE CONCLUDED THAT SOME ADDITIONAL FORCE APPLIED TO THE SAFETY SIDE CONTRIBUTED TO THE SAFETY SIDE DAMAGE. THE CITADEL PLUS BED (S/N (B)(6)) WAS BEING CHECKED DURING QUALITY INSPECTION GATE TO VERIFY THE REQUIRED PRODUCT SPECIFICATIONS AND CHECK WHETHER THE ACCEPTANCE PERFORMANCE CRITERIA ARE MET. RECORDS OF THE INSPECTION ARE DOCUMENTED IN THE DEVICE HISTORY RECORD (DHR). THE DEVICE HISTORY RECORD HAS BEEN REVIEWED FOR THIS SPECIFIC DEVICE AND NO ANOMALY WAS FOUND. IN SUMMARY, ALTHOUGH NO ADVERSE EVENT OCCURRED THE COMPLAINT WAS DECIDED TO BE REPORTABLE ON POTENTIAL AS THE SAFETY SIDE DETACHED FROM THE BED POSING A POTENTIAL RISK OF PATIENT FALLING. UPON THE INVESTIGATION CONDUCTED WE WERE ABLE TO DETERMINE THAT THE DEVICE WAS EXPOSED TO ENORMOUS FORCE THAT IS UNLIKELY TO OCCUR DURING NORMAL, INTENDED USE. THERE WAS A PATIENT LYING ON THE BED AT THE TIME THE ISSUE WAS DISCOVERED. THE SAFETY SIDE WAS REPORTED TO DETACH AND FROM THAT PERSPECTIVE THE CITADEL PLUS BED DID NOT MEET MANUFACTURER'S SPECIFICATION

    Description of Event or Problem · 0

    ON 2018-DEC-04 ARJO WAS NOTIFIED ABOUT THE CITADEL PLUS BED MALFUNCTION. UPON TECHNICIAN'S ARRIVAL TO THE CUSTOMER IT WAS DISCOVERED THAT THE PATIENT LOWER LEFT SAFETY SIDE WAS ON, BUT FALLING OFF THE HINGE. PATIENT WAS MOVED FROM THIS BED TO ANOTHER BED FOR SAFETY CONCERNS. THERE WAS NO INJURY NOR OTHER MEDICAL CONSEQUENCES REPORTED. THE DEVICE WAS TAKEN TO THE SERVICE CENTER FOR A REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8414 CITADEL PLUS BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP Z O. O. FX811B3B4AMABB 05055982756532

    Patients

    Seq Age Sex Outcome Treatment
    1 Other