BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 9000X

    MDR report key: 7250825 · Received February 8, 2018

    Report

    Report Number
    3007420694-2018-00040
    Event Type
    Malfunction
    Date Received
    February 8, 2018
    Date of Event
    January 5, 2018
    Report Date
    April 12, 2018
    Manufacturer
    ARJOHUNTLEIGH POLSKA
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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) ). ON 09-JAN-2018 ARJOHUNTLEIGH RECEIVED A CUSTOMER COMPLAINT INVOLVING ENTERPRISE 9000X. THE REPORTED MALFUNCTION TOOK PLACE IN THE HOSPITAL D'AVRANCHES IN FRANCE. FOLLOWING INFORMATION PROVIDED THE BACKREST AND LEG SECTION OF THE BED MOVED WITHOUT ANY BUTTON BEING PUSHED NEITHER ON HAND CONTROL NOR CONTROL PANEL. AT THE TIME THE UNINTENDED BED MOVEMENT OCCURRED THE PATIENT WAS BEING INTUBATED. THE PATIENT'S INTUBATION WAS SUCCESSFULLY PERFORMED, NO INJURY NOR OTHER MEDICAL CONSEQUENCES WERE REPORTED. IT NEEDS TO BE EMPHASIZED THAT ALL MANUFACTURED ENTERPRISE 9000X ARE CHECKED BEFORE BEING DISTRIBUTED TO THE CUSTOMERS TO VERIFY IF THE PRODUCT MEETS THE REQUIRED MANUFACTURER'S SPECIFICATIONS AND CHECK WHETHER THE ACCEPTANCE 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. AFTER THE EVENT AN ARJOHUNTLEIGH TECHNICIAN INSPECTED THE BED AND REVEALED THAT NO FAULT WAS FOUND WITHIN THE DEVICE. ALL BED FUNCTIONS OPERATED AS INTENDED. ARJOHUNTLEIGH REPRESENTATIVE WAS NOT ABLE TO CONFIRMED IF THERE WAS ANY OBSTACLE NEAR SAFETY SIDE PANEL THAT WOULD UNINTENTIONALLY ACTIVATE CONTROL PANEL BUTTONS BUILT UP IN SAFETY SIDES. MOREOVER IT REMIND UNKNOWN IF THE CONTROL PANEL FUNCTIONS WERE LOCKED AT THE TIME THE UNDESIRED MOVEMENT OF THE BED OCCURRED. THE BED IN QUESTION WAS NOT UNDER ARJOHUNTLEIGH SERVICE CONTRACT. THE PREVENTIVE MAINTENANCE SCHEDULE WAS NOT MADE AVAILABLE THEREFORE WE ARE NOT IN A POSITION TO DETERMINE IF ADEQUATE PREVENTATIVE MAINTENANCE WAS PERFORMED IN ACCORDANCE WITH OUR RECOMMENDATIONS. ON 06-MAR-2018 WE WERE INFORMED THAT THE FACILITY DIRECTOR DECIDED TO ISOLATE THE BED (SET IN A CERTAIN POSITION) FOR A MONTH TO SEE IF THE BED WOULD MAKE AN UNCONTROLLED MOVEMENT. BED'S TESTING WAS FINISHED ON 04-APR-2018 WITH A POSITIVE RESULT, THE UNCOMMANDED BED MOVEMENT DID NOT OCCUR. UPON THE CONDUCTED INVESTIGATION AND BED INSPECTION DONE BY THE ARJOHUNTLEIGH REPRESENTATIVE, WE WERE UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF CLAIMED FAILURE AS THE MALFUNCTION COULD NOT BE RECREATED AND NO FAULT WAS FOUND WITHIN THE DEVICE. TO ENSURE THE SAFETY OF OUR PRODUCTS THE INSTRUCTION FOR USE PROVIDED TOGETHER WITH THE INVOLVED DEVICE (746-591_EN_5 DATED ON MAY 2016) INCLUDES INFORMATION REGARDING THE POSSIBILITY OF ACTIVATING THE BEDS FUNCTION WITHOUT THE INTENTION AND HOW THIS SITUATION CAN BE AVOIDED: - WARNING: "IT IS RECOMMENDED TO USE THE FUNCTION LOCKOUT FACILITY ON THE ATTENDANT CONTROL PANEL TO PREVENT UNINTENDED MOVEMENT IN SITUATIONS WHERE OBJECTS MAY PRESS AGAINST THE PATIENTS' CONTROLS", - WARNING: " STORE THE HANDSET ON THE SIDE RAIL USING THE CLIP ON THE BACK; THIS WILL HELP TO PREVENT ACCIDENTAL OPERATION OF THE CONTROLS", - WARNING: "TAKE CARE NOT TO SQUEEZE OR TRAP THE HANDSET CABLE BETWEEN MOVING PARTS OF THE BED" - WARNING: "THE CONTROLS REQUIRE ONLY A SINGLE PRESS TO ACTIVATE. TO PREVENT UNWANTED MOVEMENTS OF THE MATTRESS PLATFORM, AVOID LEANING AGAINST THE SIDE RAILS AND KEEP EQUIPMENT ON AND AROUND THE BED CLEAR OF THE CONTROLS" - INFORMATION: "FUNCTION LOCKOUT CAN BE USED TO PREVENT OPERATION OF THE CONTROLS, E.G. WHEN INADVERTENT MOVEMENT OF THE MATTRESS PLATFORM COULD INJURE THE PATIENT." ALTHOUGH NO INJURIES WERE REPORTED, THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO THE UNCOMMANDED BED MOVEMENT OCCURRENCE. UPON THE CONDUCTED INVESTIGATION AND BED'S TESTING DONE AT CUSTOMER SITE, WE WERE UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF CLAIMED FAILURE. AT THE TIME THE UNINTENDED BED MOVEMENT OCCURRED THE PATIENT WAS BEING USED FOR PATIENT THERAPY. THE REPORTED MALFUNCTION COULD NOT BE RECREATED AND NO FAULT WAS FOUND WITHIN THE DEVICE. THE DEVICE WAS REPORTED TO MOVE ON ITS OWN AND FROM THAT PERSPECTIVE, THE ENTERPRISE 9000X BED DID NOT MEET ITS MANUFACTURER'S SPECIFICATION.

    Description of Event or Problem · 0

    ON (B)(6) 2018 ARJOHUNTLEIGH WAS NOTIFIED ABOUT THE MALFUNCTION INCOLVING ENTERPRISE 9000X BED. FOLLOWING THE INFORMATION PROVIDED THE BACKREST SECTION OF THE BED MOVED ON ITS OWN DURING PATIENT'S INTUBATION. THERE WAS NO INJURY SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98479 ENTERPRISE 9000X BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA 9X21AJ001DAABA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other