BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 5000

    MDR report key: 17432066 · Received August 1, 2023

    Report

    Report Number
    3007420694-2023-00179
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 1, 2023
    Report Date
    August 1, 2023
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DESPITE THE LACK OF CIRCUMSTANCES IN WHICH THE DAMAGES OCCURRED PROVIDED BY THE FACILITY STAFF, THE MOST PROBABLE CAUSE CAN BE DETERMINED BASED ON THE DEVICE EVALUATION RESULTS AND REVIEW OF THE POST MARKET SURVEILLANCE DATA. THE CAUSE MIGHT HAVE BEEN AN OBSTACLE MET BY THE BED DURING ITS OPERATION THAT COULD BLOCKED THE BED MOVEMENT AND THIS COULD CONTRIBUTED TO THE BED DAMAGE. THE INSTRUCTIONS FOR USE FOR ENTERPRISE 5000 (746-449) INFORMS THE USER: "WHEN THE BED IS OPERATED, MAKE SURE THAT OBSTACLES SUCH AS BEDSIDE FURNITURE DO NOT RESTRICT ITS MOVEMENT." ARJO DEVICE FAILED TO MEET ITS PERFORMANCE SPECIFICATION SINCE DAMAGED COMPONENTS WERE OBSERVED. THIS COMPLAINT IS DEEMED REPORTABLE DUE TO ALLEGATION OF HINGE BREAKAGE DURING USE OF THE BED WITH THE PATIENT. NO INJURY OCCURRED AS AN OUTCOME OF THE CLAIMED MALFUNCTION.

    Description of Event or Problem · 0

    THE CUSTOMER'S ALLEGATION WAS THAT THE MIDDLE OF THE BED BROKE WITH A PATIENT ON IT. NO INJURY WAS SUSTAINED. UPON THE EVALUATION PERFORMED BY THE ARJO SERVICE TECHNICIAN IT WAS CONFIRMED THAT ONE BACKREST HINGE BROKE INTO TWO PIECES, THE SECOND ONE AND THE BACKREST ASSEMBLY WERE BENT AND THE COVER OF THE BACKREST ACTUATOR WAS CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344394 ENTERPRISE 5000 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. 5000BE42A12BA

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other