BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 8000

    MDR report key: 20451371 · Received October 15, 2024

    Report

    Report Number
    3007420694-2024-00262
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 16, 2024
    Report Date
    October 15, 2024
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHOTOGRAPHIC EVIDENCE PROVIDED CONFIRMED THAT THE BACKREST HINGE BROKE INTO TWO PIECES. IN ADDITION, IT WAS FOUND THE BACKREST ACTUATOR WAS PHYSICALLY BROKEN. THE ISSUE WAS CONSULTED WITH THE ARJO FIELD SERVICE ENGINEER WHO ADVISED THAT THE MOST PROBABLE ROOT CAUSE IS THE MISUSE DURING OPERATING THE BED. THE INSTRUCTIONS FOR USE FOR ENTERPRISE 8000 (746-435-UK-7¿ 04/2011 THE LATEST VERSION STORED) INDICATES THAT:"WHEN THE BED IS OPERATED, MAKE SURE THAT OBSTACLES SUCH AS BEDSIDE FURNITURE DO NOT RESTRICT MOVEMENT." BASED ON THE INFORMATION RECEIVED DURING THE CAPA INVESTIGATION PROCESS THE BACKREST HINGES MIGHT BREAK WHEN EXTERNAL FORCE IS APPLIED OR THE FRAME IS BEING BLOCKED. ARJO DEVICE FAILED TO MEET ITS SPECIFICATIONS WHEN THE BACKREST HINGES AND THE ACTUATOR WERE BROKEN. THE BED WAS IN USE FOR THE PATIENT'S TREATMENT WHEN HINGES BREAKAGES OCCURRED. THE COMPLAINT WAS ASSESSED AS REPORTABLE DUE TO THE ALLEGATION THAT THE BACKREST HINGES BROKE WHILE THE PATIENT WAS ON THE BED. NOTE: UDI NUMBERS WERE NOT APPLICABLE FOR THE DEVICE MANUFACTURED IN 2009.

    Description of Event or Problem · 0

    FOLLOWING THE INFORMATION GATHERED, THE BACKREST HINGES BECAME DAMAGED DURING USE WITH A PATIENT. IN ADDITION, THE BACKREST ACTUATOR WAS FOUND TO BE BROKEN PHYSICALLY. NO INJURY WAS SUSTAINED. THE HINGES AND THE BACKREST ACTUATOR WAS REPLACED. THE DEVICE STARTED TO OPERATE CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31827 ENTERPRISE 8000 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. 8000BA22A12EA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other