BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 9000X

    MDR report key: 7163303 · Received January 4, 2018

    Report

    Report Number
    3007420694-2018-00002
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Report Date
    June 19, 2018
    Manufacturer
    ARJOHUNTLEIGH POLSKA
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 06-DEC-2017 ARJO RECEIVED A CUSTOMER COMPLAINT INVOLVING ENTERPRISE 9000X. THE REPORTED MALFUNCTION TOOK PLACE IN THE UNIVERSITY HOSPITAL DURHAM IN GREAT BRITAIN. FOLLOWING INFORMATION PROVIDED THE BACKREST 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 LYING ON THE BED. NO INJURY NOR OTHER MEDICAL CONSEQUENCES WERE REPORTED. AFTER THE MALFUNCTION OCCURRENCE THE BED WAS INSPECTED WITH REGARDS TO THE ALLEGED ISSUE. ACCORDING TO THE INFORMATION PROVIDED BY ARJO TECHNICIAN NO FAULT WAS FOUND WITHIN THE DEVICE. ALL BED FUNCTIONS OPERATED AS INTENDED. IT WAS CONFIRMED BY FACILITY STAFF THAT THERE WAS NO OBSTACLE NEAR SAFETY SIDE PANEL THAT WOULD UNINTENTIONALLY ACTIVATE CONTROL PANEL BUTTONS BUILT UP IN SAFETY SIDES. IT REMAINED UNKNOWN IF THE CONTROL PANEL FUNCTIONS WERE LOCKED AT THE TIME THE UNDESIRED MOVEMENT OF THE BED OCCURRED. THE BED IN QUESTION WAS UNDER WARRANTY THE PREVENTATIVE MAINTENANCE WAS PERFORMED REGULARLY IN ACCORDANCE WITH OUR RECOMMENDATIONS. AS (B)(6) HOSPITAL IN DURHAM OBSERVED THE SIMILAR UNCOMMANDED FAILURES IN THE PAST (RECORDED UNDER ARJO INTERNAL NUMBER: (B)(4)), ARJO DECIDED TO INVESTIGATE THE REPORTED SYMPTOM DEEPER AND INITIATED THE ENTERPRISE 9000X RETURN TO CONDUCT TECHNICAL EVALUATION. ON 08-JAN-2018 THE BED FROM THE COMPLAINT (B)(4) (FIRST COMPLAINT FROM THIS FACILITY) WAS RETURNED TO THE ARJO POLSKA SP. Z O.O. ON 12-FEB-2018 ARJO TECHNICAL DEPARTMENT STARTED TESTING THE BED. THE MAIN OBJECTIVE OF THE TEST WAS TO OBSERVE THE BED FOR 2 MONTHS IN REGARDS TO UNINTENDED BED'S MOVEMENT TO SEE IF ANY MOVEMENT WOULD BE DETECTED. THE BED WAS PLACED IN A QUARANTINED IN ARJO POLSKA SP. Z O.O. TEST AREA. THE BACKREST SECTION OF THE BED WAS LEFT IN THE CONDITION IN WHICH IT WAS DELIVERED. THE BACKREST AND LEG ANGLE WAS MEASURED AND DOCUMENTED AS WELL AS PLATFORM'S HEIGHT. THE ANGLES WERE EQUAL TO 0°. THE BED WAS CONNECTED TO THE MAINS LEAD. POWER SUPPLY NETWORK 230V, 60HZ. THE CONTROL PANEL'S LOCK OUT WAS NOT ACTIVATED. ADDITIONALLY THE BED WAS LOADED WITH A BALLAST WEIGHT (75KG) TO SIMULATE PATIENT'S PRESENCE. WEIGHT WAS DISTRIBUTED IN ACCORDANCE TO IEC 60601-2-52: BACKREST SECTION- 35KG. SEAT SECTION- 20KG. LEG SECTION- 25 KG. THE VIDEO CAMERA WITH MOTION RECORDER WAS SETUP TO RECORD AS SOON AS ANY MOVEMENT WOULD BE DETECTED. THE BED WAS OBSERVED FOR 2 MONTHS (SINCE 12-FEB-2018 TILL 12-APR-2018). DURING 2 MONTHS OF BED'S TESTING WE WERE NOT ABLE TO RECREATE THE UNCOMMANDED BED MOVEMENT OCCURRENCE. NO BED MOVEMENT WAS RECORDED BY CAMERA. ADDITIONALLY ON 2018-MAY-17 THE BED WAS SUBJECTED TO EXTERNAL ELECTROMAGNETIC COMPATIBILITY (EMC) TESTS TO VERIFY IF THE BED IS COMPLIANT WITH IMMUNITY REQUIREMENTS FROM EN 60601-1-2:2007 EMC STANDARD. ALL TESTS WERE PASSED SUCCESSFULLY, NO UNCOMMANDED MOVEMENT WAS OBSERVED. SUMMARIZING, ALTHOUGH THE BED WAS COMPREHENSIVELY TESTED WE WERE UNABLE TO RECREATE ALLEGED SCENARIO, HOWEVER WE RULED OUT THE ELECTROMAGNETIC INCOMPATIBILITY TO BE THE CAUSE OF UNCOMMANDED MOVEMENT OCCURRENCE. 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. THE DEVICE HISTORY RECORD HAS BEEN REVIEWED FOR THIS SPECIFIC DEVICE AND NO ANOMALY WAS FOUND. THE INSTRUCTION FOR USE PROVIDED TOGETHER WITH THE INVOLVED DEVICE (746-591_EN_8 DATED ON JAN 2017) 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 IN RELATION TO THIS INCIDENT, THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO THE UNCOMMANDED BED MOVEMENT OCCURRENCE. UPON THE CONDUCTED INVESTIGATION AND BED'S TESTING, WE WERE UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF CLAIMED FAILURE. 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 PERFORMANCE SPECIFICATION.

    Additional Manufacturer Narrative · 0

    AS THIS IS ONE OF THE 5 CUSTOMER COMPLAINTS ((B)(4)) FROM THE SAME BED'S BATCH FROM (B)(4) FACILITY CONCERNING INVOLUNTARY DEVICE MOVEMENT IT WAS DECIDED TO RETURN ONE OF 5 BEDS FROM MARKET FOR TESTING. THE BED RETURNED FROM MARKET DERIVES FROM COMPLAINT (B)(4) - 3007420694-2017-00081 (FIRST COMPLAINT WITH THIS FAULT DESCRIPTION FROM (B)(4) FACILITY) AND IS GOING TO BE THE SAMPLE OF 5 REPORTED BEDS. THE BED WAS PLACED IN A QUARANTINED IN ARJO (B)(4) TEST AREA. THE BACKREST SECTION OF THE BED WAS LEFT IN THE CONDITION IN WHICH IT WAS DELIVERED. THE BACKREST AND LEG ANGLE WAS MEASURED AND DOCUMENTED AS WELL AS PLATFORM'S HEIGHT. THE BED WAS CONNECTED TO THE MAINS LEAD. THE CONTROL PANEL'S LOCK WAS NOT ACTIVATED (AS IN CASE OF CUSTOMER COMPLAINT (B)(4)). ADDITIONALLY THE BED WAS LOADED WITH A MANNEQUIN (75KG) TO SIMULATE PATIENT'S PRESENCE. THE VIDEO CAMERA WITH MOTION RECORDER WAS SETUP TO RECORD AS SOON AS ANY MOVEMENT WOULD BE DETECTED. THE TEST LASTED 2 MONTHS. DURING THAT TIME THE INVOLUNTARY MOVEMENT DID NOT OCCUR. ADDITIONALLY WE ARE GOING TO SEND THE BED FOR ELECTRO-MAGNETIC COMPATIBILITY (EMC) TEST. THE FINAL REPORT WILL BE SEND UPON EMC TEST REPORT RECEIPT.

    Description of Event or Problem · 0

    ON (B)(6) 2017 ARJOHUNTLEIGH WAS NOTIFIED ABOUT THE COMPLAINT INVOLVING ENTERPRISE 9000X BED. THE REPORTED MALFUNCTION TOOK PLACE IN THE (B)(6) HOSPITAL(B)(6) IN (B)(6). FOLLOWING THE INFORMATION REPORTED THE BED MOVED UN-COMMANDED WITH PATIENT ON BED. THERE WAS NO INJURY REPORTED IN RELATIONS TO THE THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8549 ENTERPRISE 9000X BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA 9X22BB101BAAAA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other