BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON B-810

    MDR report key: 501562 · Received December 3, 2003

    Report

    Report Number
    501562
    Event Type
    Malfunction
    Date Received
    December 3, 2003
    Date of Event
    October 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    BERCHTOLD CORP
    Product Code
    FWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE BED, AN OPERON B810, DID NOT MAINTAIN PROPER POSITION DUE TO A MALFUNCTION IN THE HYDRAULIC PRESSURE SYSTEM (MOST LIKELY AN "O" RING PROBLEM AS PER THE MANUFACTURER, THE BERCHTOLD CO.) THE PATIENT NEARLY FELL OFF OF THE BED. THE PATIENT'S SURGICAL PROCEDURE HAD TO BE CANCELLED AS A RESULT OF THE BED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERON B-810 SURGICAL TABLE FWY BERCHTOLD CORP B 810 *

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other