BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE 9000X

    MDR report key: 9581256 · Received January 13, 2020

    Report

    Report Number
    3007420694-2020-00005
    Event Type
    Injury
    Date Received
    January 13, 2020
    Report Date
    April 29, 2020
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    UDI-DI
    05055982754071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ARJO WAS INFORMED ABOUT TWO INCIDENTS THAT OCCURRED IN ALTNAGELVIN AREA HOSPITAL IN NORTHERN IRELAND (SUBMITTED UNDER TWO SEPARATE REGULATORY REPORTS USING THE FOLLOWING MHRA REFERENCE NUMBERS: 2020/001/013/601/006, 2020/001/013/301/007). IT WAS REPORTED THAT THE BACKREST SECTION OF THE BED RAISED UNEXPECTEDLY WHEN THE PATIENT WAS LYING ON THE BED. THIS SITUATION WAS OBSERVED TWICE WITHIN ONE WEEK. THE PATIENT INFORMATION WAS NOT PROVIDED, THEREFORE IT COULD NOT BE CONFIRMED WHETHER ONE OR TWO DIFFERENT PATIENTS WERE INVOLVED IN THESE INCIDENTS. THERE WAS NO INJURY NOR OTHER MEDICAL CONSEQUENCES REPORTED. THE BED WAS REPLACED BY THE NEW ONE AND THE INVOLVED RETURNED TO THE ARJO SERVICE CENTER FOR INSPECTION. THE DEVICE INSPECTION CONFIRMED THAT THE BUTTON, RESPONSIBLE FOR RAISING THE BACKREST, LOCATED ON THE CONTROL PANEL INSIDE THE RIGHT HEAD-END SIDE RAIL DID NOT FUNCTION PROPERLY, CAUSING THE BACKREST TO RAISE ON ITS OWN. THERE WERE NO OTHER DAMAGES FOUND. IN SUMMARY, THE INVOLVED ENTERPRISE 9000X WAS USED WITH THE PATIENT WHEN THE BACKREST SECTION MOVED UNEXPECTEDLY. THERE WAS A MALFUNCTIONING BUTTON ON THE CONTROL PANEL DETECTED, THEREFORE THE BED DID NOT MEET THE MANUFACTURER¿S SPECIFICATIONS. ALTHOUGH NO INJURY WAS REPORTED, THE COMPLAINT DECIDED TO BE REPORTABLE IN AN ABUNDANCE OF CAUTION DUE TO UNINTENDED BACKREST MOVEMENT.

    Additional Manufacturer Narrative · 0

    MHRA REFERENCE NUMBERS IN THE H10 SECTION WERE REPLACED BY ESTABLISHMENT NUMBERS. ARJO WAS INFORMED ABOUT TWO INCIDENTS THAT OCCURRED IN ALTNAGELVIN AREA HOSPITAL IN NORTHERN IRELAND (SUBMITTED UNDER TWO SEPARATE REGULATORY REPORTS USING THE FOLLOWING ESTABLISHMENT NUMBERS: 3007420694-2020-00005; 3007420694-2020-00004). IT WAS REPORTED THAT THE BACKREST SECTION OF THE BED RAISED UNEXPECTEDLY WHEN THE PATIENT WAS LYING ON THE BED. THIS SITUATION WAS OBSERVED TWICE WITHIN ONE WEEK. THE PATIENT INFORMATION WAS NOT PROVIDED, THEREFORE IT COULD NOT BE CONFIRMED WHETHER ONE OR TWO DIFFERENT PATIENTS WERE INVOLVED IN THESE INCIDENTS. THERE WAS NO INJURY NOR OTHER MEDICAL CONSEQUENCES REPORTED. THE BED WAS REPLACED BY THE NEW ONE AND THE INVOLVED RETURNED TO THE ARJO SERVICE CENTER FOR INSPECTION. THE DEVICE INSPECTION CONFIRMED THAT THE BUTTON, RESPONSIBLE FOR RAISING THE BACKREST, LOCATED ON THE CONTROL PANEL INSIDE THE RIGHT HEAD-END SIDE RAIL DID NOT FUNCTION PROPERLY, CAUSING THE BACKREST TO RAISE ON ITS OWN. THERE WERE NO OTHER DAMAGES FOUND. IN SUMMARY, THE INVOLVED ENTERPRISE 9000X WAS USED WITH THE PATIENT WHEN THE BACKREST SECTION MOVED UNEXPECTEDLY. THERE WAS A MALFUNCTIONING BUTTON ON THE CONTROL PANEL DETECTED, THEREFORE THE BED DID NOT MEET THE MANUFACTURER¿S SPECIFICATIONS. ALTHOUGH NO INJURY WAS REPORTED, THE COMPLAINT DECIDED TO BE REPORTABLE IN AN ABUNDANCE OF CAUTION DUE TO UNINTENDED BACKREST MOVEMENT.

    Additional Manufacturer Narrative · 0

    DURING EVALUATION OF THE BED BY ARJO TECHNICIAN, THE REPORTED BACKREST UNINTENDED MOVEMENT WAS RECREATED. IT WAS OBSERVED THAT BUTTON LOCATED ON THE INSIDE PANEL OF HEAD END SPLIT SIDE RAIL ( RESPONSIBLE FOR RAISING OF THE BACKREST SECTION) WAS DEFECTIVE AND MAY CAUSED THIS UNINTENDED MOVEMENT. THE ANALYSIS IS STILL ONGOING. MORE DETAILS WILL BE PROVIDED TO THE NEXT FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 0

    TO IDENTIFY THE CAUSE OF THE REPORTED UNINTENDED MOVEMENT OF THE BACKREST, IT WAS DECIDED TO RETURN SOME SAMPLES FOR THE DETAILED INVESTIGATION TO THE MANUFACTURER- FACTORY IN POZNAN. THESE SAMPLES WERE RETURNED ON 09 MAR 2020. THE RESULTS OF THE EVALUATION WILL BE PROVIDED TO THE NEXT FOLLOW UP REPORT UPON INVESTIGATION COMPLETION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. MORE DETAILS WILL BE PROVIDED TO THE FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY (B)(6) HOSPITAL IN (B)(6) THAT THE BACKREST RAISED UNINTENDED WITHOUT ANY COMMAND GIVEN. IT TOOK PLACE TWICE, THIS REPORT IS RELATED TO THE SECOND CASE. THE PATIENT WAS LYING ON THE BED WHEN THIS ISSUE WAS NOTICED, HOWEVER THERE WAS NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44466 ENTERPRISE 9000X BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. 9X22BB101BAAAA 05055982754071

    Patients

    Seq Age Sex Outcome Treatment
    1 Other