BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPERON

    MDR report key: 2401409 · Received December 30, 2011

    Report

    Report Number
    1220685-2011-00007
    Event Type
    Malfunction
    Date Received
    December 30, 2011
    Date of Event
    December 8, 2011
    Report Date
    December 27, 2011
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS EVALUATED BY A BERCHTOLD CORP. SERVICE TECHNICIAN ON (B)(4) 2011 AFTER THE INCIDENT AT THE LOCATION WHERE THE INCIDENT OCCURRED. THE PROBLEM WAS DUPLICATED. THE PROBLEM WAS DETERMINED TO BE A FAULTY LEG AND BACK SENSOR HARNESS. THE HARNESS WAS REPLACED AND THE PROBLEM WAS CORRECTED. THE TABLE WAS TURNED BACK OVER TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    WITH A PATIENT ON THE TABLE DURING A PROCEDURE, THE RETURN TO LEVEL BUTTON WAS PRESSED AND THE HEAD AND FOOT SECTIONS OF THE TABLE LOWERED. NO PATIENT INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPERON SURGICAL TABLE FQO BERCHTOLD CORP. B810

    Patients

    Seq Age Sex Outcome Treatment
    1