BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 8000

    MDR report key: 18524335 · Received January 17, 2024

    Report

    Report Number
    3007420694-2024-00017
    Event Type
    Malfunction
    Date Received
    January 17, 2024
    Date of Event
    December 21, 2023
    Report Date
    February 15, 2024
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. FURTHER INFORMATION WILL BE AVAILABLE IN THE NEXT EXPECTED REPORT.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION GATHERED, IT IS MOST LIKELY THAT THE CAUSE OF THE DAMAGE TO THE POWER CORD AND THE BURN MARKS COULD HAVE BEEN A USAGE ERROR. ACCORDING TO THE ARJO SERVICE TECHNICIAN WHO EVALUATED THE BED, THE DAMAGE WAS MOST LIKELY THE RESULT OF THE POWER CORD BEING TWISTED AND BECOMING TRAPPED. THE INSTRUCTIONS FOR USE FOR ENTERPRISE 8000 (746-435-UK REV. 6) INCLUDES THE FOLLOWING INFORMATION RELATED TO THE SUBJECT OF THE INVESTIGATION: "THE ELECTRICAL SUPPLY CABLE IS FITTED WITH A PLASTIC HOOK. WHEN NOT IN USE OR BEFORE MOVING THE BED, CLIP THE HOOK ONTO THE HEAD END PANEL, COIL UP THE CABLE AND PLACE IT OVER THE HOOK". "MAKE SURE THAT THE CABLES DO NOT BECOME ENTANGLED WITH MOVONG PARTS OF THE BED". "DISCONNECT THE ELECTRICAL SUPPLY CABLE FROM THE ELECTRICITY SUPPLY, AND STORE IT (...), BEFORE MOVING THE BED". THE POWER CORD WAS REPLACED BY THE ARJO SERVICE TECHNICIAN. ARJO DEVICE FAILED TO MEET ITS SPECIFICATION AS THE POWER CORD WAS DAMAGED. THE DEVICE WAS NOT USED WITH A PATIENT WHEN THE FAILURE WAS NOTICED. THE COMPLAINT DECIDED TO BE REPORTABLE DUE TO FIRE REPORTED. NO INJURY WAS REPORTED.

    Description of Event or Problem · 0

    DURING A SERVICE VISIT AN ARJO SERVICE TECHNICIAN FOUND THE POWER CORD FAILURE OF THE ENTERPRISE 8000 BED. IT WAS INDICATED THAT THERE WAS A SHORT CUT IN THE CABLE WHICH CAUSES MARKS OF BURNING. SHORT CUT WAS CAUSED BY INTERNAL ISOLATION DAMAGE. NO PATIENT INVOLVEMENT AND NO INJURIES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1693310 ENTERPRISE 8000 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. 8000BC42A11BH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other