BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 8000

    MDR report key: 23242363 · Received October 8, 2025

    Report

    Report Number
    3007420694-2025-00249
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    September 17, 2025
    Report Date
    October 8, 2025
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE INSTRUCTIONS FOR USE FOR THE ENTERPRISE 8000 ((746-571-UK-2) "IT IS RECOMMENDED TO USE THE FUNCTION LOCKOUT FACILITY ON THE ATTENDANT CONTROL PANEL (ACP) TO PREVENT UNINTENDED MOVEMENT." THE FACILITY CLAIMED THAT THE BED WAS LOWERING ON ITS OWN; HOWEVER THERE WAS FOUND NO ISSUE WITH THE BED AT ALL, AND THE ENGINEER COULD NOT DUPLICATE THE REPORTED SCENARIO. IN ADDITION, IFU WARNS THE USER, "BEFORE OPERATING THE BED, MAKE SURE THAT THE PATIENT IS POSITIONED CORRECTLY TO AVOID ENTRAPMENT OR IMBALANCE." TAKING INTO CONSIDERATION THAT NO MALFUNCTION WAS IDENTIFIED, THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED. ARJO DEVICE DID NOT FAIL ITS SPECIFICATION, NO MALFUNCTION COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE FOUND. THE DEVICE WAS USED FOR THE PATIENT TREATMENT AT THE TIME OF THE INCIDENT AND FROM THAT PERSPECTIVE, IT PLAYED A ROLE IN THE EVENT. THE COMPLAINT WAS ASSESSED AS REPORTABLE DUE TO THE ALLEGATION THAT THE BACKREST SECTION UNINTENTIONALLY LOWERED WITHOUT ANY BUTTONS BEING PRESSED AND TRAPPED AND PATIENT'S FINGER. THE PATIENT FELT PAIN, WHICH WAS ASSESSED AS A MINOR INJURY. NO UDI INFORMATION IS AVAILABLE, THE DEVICE WAS MANUFACTURED BEFORE UDI IMPLEMENTATION.

    Description of Event or Problem · 0

    IT WAS CLAIMED BY A CUSTOMER THAT THE BACKREST FRAME SUDDENLY DROPPED DOWN WITHOUT PRESSING ANY BUTTON, WHILE THE PATIENT SAT DOWN ON THE BED. THE BACKREST WAS AT APPROXIMATELY 30 DEGREE, AND STARTED TO LOWER SLOWLY, BUT UNEXPECTEDLY, LIKE SOMEONE PRESSING THE HANDSET, BUT IT WAS NOT. THE PATIENT TRAPPED HIS FINGER AND HE FELT PAIN. NO INTERVENTION WAS REQUIRED. ARJO ENGINEER CHECKED THE DEVICE, AND NO ISSUE WAS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2583983 ENTERPRISE 8000 BED, AC-POWERED ADJUSTABLE HOSPITAL FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. 8000KA24A52BA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other