BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE 9000

    MDR report key: 2824461 · Received October 26, 2012

    Report

    Report Number
    3007420694-2012-00054
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Date of Event
    October 11, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ARJOHUNTLEIGH POLSKA SP. Z O.O.
    Product Code
    FNL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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). ADDITIONAL INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    INCIDENT OCCURRED ON A BED ENTERPRISE 9000 INSTALLED IN THE ICU. THE BED WAS OCCUPIED BY A PT INTUBATED AND BACKREST OF THE BED HAS BEEN TYPICALLY POSITIONED AT 45 DEGREES WHEN THE BACKREST SECTION COLLAPSED. SALES AND SERVICE TECH HAS INSPECTED THE BED AND HAVE FOUND A SPRING UNDER THE BED. WHEN THEY REMOVED A LABEL COVER (GLUED) FROM THE HINGE, THE SCREW FELL OUT. THE TECHNICIAN HAS NOTICED THAT ON ONE OF THE HINGES BREAKAGE START TO OCCUR. NO DEATH OR SERIOUS INJURY HAS BEEN REPORTED. NO INJURIES WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE 9000 MEDICAL BED FNL ARJOHUNTLEIGH POLSKA SP. Z O.O. ENT9000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other