BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 8000X

    MDR report key: 5881684 · Received August 17, 2016

    Report

    Report Number
    3007420694-2016-00178
    Event Type
    Malfunction
    Date Received
    August 17, 2016
    Date of Event
    July 20, 2016
    Report Date
    July 20, 2016
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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). ARJOHUNTLEIGH RECEIVED A COMPLAINT ON ENTERPRISE 8000X ON 2016-JUL-25 WITH REGARDS TO A PROBLEM CONCERNING THE UNINTENDED MOVEMENT. CUSTOMER CLAIMED THAT THE BED IS NOT WORKING PROPERLY. ARJOHUNTLEIGH SERVICE TECHNICIAN INVESTIGATED THE ISSUE AND FOUND OUT THAT THE BACKREST IS AUTOMATICALLY MOVING UP WHEN THE NURSE-PATIENT CONTROL PANEL IS CONNECTED. A REVIEW OF STANDARD AND REPORTABLE COMPLAINTS WAS PERFORMED SHOWING THERE IS NO TREND OBSERVED FOR REPORTABLE COMPLAINTS WITH THIS FAILURE FOR ENTERPRISE 8000X AND 9000X FOR THESE KINDS OF EVENTS. THE DEVICE DID FAIL TO MEET SPECIFICATIONS SINCE THE ARJOHUNTLEIGH SERVICE TECHNICIAN REPLACED THE FAULTY NURSE-PATIENT CONTROL PANEL AND THEN THE BED WAS WORKING AS INTENDED. DEVICE HISTORY REVIEW DID NOT SHOW ANY DISCREPANCIES THAT COULD LEAD TO SUCH CONDITION. IN ACCORDANCE TO OUR BEST KNOWLEDGE PATIENT WAS NOT INVOLVED IN THE WHOLE EVENT AND NOBODY HAS SUSTAINED ANY INJURY. NONE OTHER ACTIONS THAN THE ONES ALREADY TAKEN (PART REPLACEMENT) ARE SUGGESTED SINCE THE BED IS FULLY FUNCTIONAL AFTER PERFORMED REPLACEMENT. IN SUMMARY, GIVEN THE CIRCUMSTANCES THIS INCIDENT APPEARS TO BE A RARELY OCCURRING ISSUE. OUR DEVICE - ENTERPRISE 8000X - WAS NOT USED WITH PATIENT WHEN THE INCIDENT TOOK PLACE. THERE WAS MALFUNCTIONING NURSE-PATIENT CONTROL PANEL DETECTED ON THE DEVICE. HOWEVER - NO INJURIES WERE REPORTED TO PATIENT OR CAREGIVER. NEVETHERLESS, THE COMPLAINT IS DEEMED TO BE REPORTABLE DUE TO RISK TO THE PATIENT AS IF THE FAILURE WAS TO RE-OCCUR AND DUE TO SIMILARITY TO ENTERPRISE 9000X BEDS (ENTERPRISE 8000X IS NOT REGISTERED AND DISTRIBUTED IN UNITED STATES). THIS COMPLAINT IS NOT REPORTABLE IN INDIA, AS THIS DEVICE IS NOT CONSIDERED THERE TO BE A MEDICAL DEVICE ON THAT MARKET.

    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.

    Description of Event or Problem · 0

    INITIALLY IT WAS REPORTED TO THE ARJOHUNTLEIGH'S REPRESENTATIVE THAT BED WAS NOT WORKING PROPERLY AFTER CHECKING THE DEVICE, IT WAS FOUND THAT, BACKREST FUNCTION OF BED WAS MOVING UP AUTOMATICALLY WHEN CONNECTED WITH A NURSE CONTROL PANEL. AFTER REPLACING NURSE CONTROL PANEL WITH NEW ONE, BED FUNCTIONED CORRECTLY. NO PATIENT WAS INVOLVED DURING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533550 ENTERPRISE 8000X FNL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. 8X23GC103BCBAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other