BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 8000X WITH INDIGO

    MDR report key: 7896955 · Received September 21, 2018

    Report

    Report Number
    3007420694-2018-00182
    Event Type
    Malfunction
    Date Received
    September 21, 2018
    Date of Event
    August 15, 2018
    Report Date
    October 23, 2018
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP Z O. O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    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). ON (B)(6)-2018 ARJO RECEIVED A CUSTOMER COMPLAINT INVOLVING ENTERPRISE 8000X BED EQUIPPED WITH INDIGO SYSTEM. THE REPORTED MALFUNCTION TOOK PLACE IN THE BURWOOD HOSPITAL IN NEW ZEALAND. FOLLOWING THE INFORMATION PROVIDED THE CAREGIVER WAS MOVING THE BED WITH USE OF AN INDIGO ASSIST SYSTEM BETWEEN TWO WARDS WHILE THE INDIGO UNIT DISABLED ITSELF. WHEN DISENGAGED, THE CAREGIVER APPLIED THE FOOT BRAKE PEDAL AND PUT THE INDIGO BACK INTO A STEERING MODE. AT THAT POINT THE BED STARTED MOVING BY ITSELF (FOR ABOUT 20 METERS, ACCELERATING) UNTIL THE BRAKE WAS ENGAGED. THERE WAS A PATIENT LYING ON THE BED AT THE TIME OF THE FAILURE OCCURRENCE. THERE WAS NO INJURY NOR OTHER MEDICAL CONSEQUENCE REPORTED EITHER FOR THE PATIENT OR CAREGIVER. ACCORDING TO THE INFORMATION PROVIDED BY ARJO TECHNICIAN THE INDIGO HAD DISABLED ITSELF WHILE BEING DRIVEN DOWN THE HALLWAY THAT HAS AN EXPOSED GAP BETWEEN TWO CONCRETE SLABS. DURING BED'S EVALUATION THE ARJO TECHNICIAN WAS NOT ABLE TO RECREATE REPORTED MALFUNCTION. HE CAME BACK TO THE HOSPITAL IN WHICH THE REPORTED MALFUNCTION OCCURRED IN ORDER TO MEASURE THE HALLWAY WHERE INDIGO DRIVE ASSIST WAS POSSIBLY ACTIVATED ON. THE MEASUREMENTS CONDUCTED REVEALED THAT THE HEIGHT DIFFERENCE OF THE INCLINE IS 20 MILLIMETERS. THE INCLINE AS SUCH WOULD NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. IN ADDITION, THE CASE STUDY WAS EXTENDED BY THE VERIFICATION OF DATA FROM THE INDIGO PRINTED CIRCUIT BOARD (PCB) WHICH DID NOT PRESENT ANY ANOMALIES. BASED ON ALL INFORMATION COLLECTED WE WERE NOT ABLE TO IDENTIFY A DIRECT CAUSE OF THE MALFUNCTION IN QUESTION. IT NEEDS TO BE EMPHASIZED THAT ENTERPRISE 8000X BED (SERIAL NUMBER: P0496048) EQUIPPED WITH INDIGO (SERIAL NUMBER P0482618) WAS 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 RECORDS HAVE BEEN REVIEWED FOR THIS SPECIFIC DEVICE AND NO ANOMALY THAT WOULD AFFECT INDIGO FUNCTIONALITY WAS FOUND. THE PRODUCT INSTRUCTION FOR USE (#416260 REV. B DATED ON FEB 2018) WHICH WAS SUPPLIED TOGETHER WITH THE INVOLVED DEVICE CONTAINS ALL CRUCIAL INFORMATION AND WARNINGS WHICH SHOULD BE FOLLOWED TO ENSURE PATIENT SAFETY: -WEEKLY "CHECK THAT THE INDIGO COVER IS UNDAMAGED" -DAILY "CHECK THAT INDIGO IS ACTIVATED WHEN PEDAL IS IN ITS MOST UPWARD POSITION" - "TO AVOID INJURY, ACTIVATE THE BRAKE ON THE BED AND CALL MAINTENANCE IF UNANTICIPATED MOTION OCCURS" - "TO MINIMIZE THE RISK OF SERIOUS INJURY, CAREFULLY READ AND FOLLOW ALL SAFETY INFORMATION AND OPERATING INSTRUCTIONS BEFORE OPERATING INDIGO. ENSURE ALL PHYSICIAN ORDERS AND FACILITY PROTOCOLS ARE FOLLOWED." ALTHOUGH NO INJURIES WERE REPORTED IN RELATION TO THIS INCIDENT, THE COMPLAINT WAS DECIDED TO BE REPORTABLE DUE TO THE UNCONTROLLED BED MOVEMENT OCCURRENCE AND CAUTIOUS APPROACH. THE DEVICE WAS REPORTED TO MOVE ON ITS OWN AND FROM THAT PERSPECTIVE, THE ENTERPRISE 8000X BED EQUIPPED WITH INDIGO SYSTEM DID NOT MEET MANUFACTURER'S SPECIFICATION.

    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). THE SERIAL NUMER (B)(6) INITIALY PROVIDED IN THE REPORT WAS CORRECTED INTO BED'S SERIAL NUMER. BED SERIAL NUMBER: (B)(6). INDIGO (ACCESSORY) SERIAL NUMBER: (B)(6). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 0

    FOLLOWING THE INFORMATION PROVIDED BY THE FACILITY STAFF A CAREGIVER WAS PUSHING THE BED DOWN THE MAIN CORRIDOR WITH USE OF INDIGO SYSTEM WHEN THE INDIGO DISABLED ITSELF. THEN THE CAREGIVER PUT THE BED INTO BRAKED MODE AND BACK INTO STEERING MODE TO RE-ENGAGE THE INDIGO SYSTEM. AFTERWARDS, SHE PUSHED THE BED AND IT DROVE OFF BY ITSELF FOR APPROXIMATELY 20 METERS BEFORE THE BRAKE WAS ENGAGED AGAIN BY THE CAREGIVER. THE PATIENT WAS ON THE BED AT THE TIME, NO INJURY HAS BEEN REPORTED TO EITHER THE PATIENT OR CAREGIVER. AFTER THE INCIDENT OCCURRENCE THE TECHNICIAN WAS NOT ABLE TO RECREATE REPORTED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741044 ENTERPRISE 8000X WITH INDIGO BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP Z O. O. 8X24YY113DBAGB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other