BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 5000

    MDR report key: 2718702 · Received August 23, 2012

    Report

    Report Number
    3007420694-2012-00030
    Event Type
    Malfunction
    Date Received
    August 23, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 13, 2012
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. ZO.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC ON BEHALF OF THE MFR ARJOHUNTLEIGH (B)(4). THE EVAL OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    TECH FOUND A COMPLETE LOSS OF FUNCTIONS ON THE BED. REPLACED CONTROL BOX. CPR RELEASE CABLE BROKEN - NEW CABLE REQUIRED. FITTED AND TESTED ALL OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE 5000 MEDICAL BED FNL ARJOHUNTLEIGH POLSKA SP. ZO.O. 5000BE42A12BA

    Patients

    Seq Age Sex Outcome Treatment
    1