BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERCHTOLD SURGICAL TABLES

    MDR report key: 1657390 · Received April 8, 2010

    Report

    Report Number
    1220685-2010-00001
    Event Type
    Malfunction
    Date Received
    April 8, 2010
    Date of Event
    January 28, 2010
    Report Date
    March 31, 2010
    Manufacturer
    BERCHTOLD GMBH
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    BERCHTOLD'S INTERNAL INVESTIGATION IS CURRENTLY UNDERWAY. (B)(4). THE REPORTED FAILURES ARE BELIEVED TO BE CONTRIBUTED TO THE IMPROPER ASSEMBLY PROCESS BY THE THIRD PARTY MFR OF THE HYDRAULIC SYSTEM RELATED TO A GASKET ON THE TREND CYLINDER. BERCHTOLD CORP REMOVED THE TABLE FROM SERVICE AND RETURNED IT TO (B)(4) FOR FURTHER EVALUATION. (B)(4) EVALUATION, ONCE DUPLICATED, SHOWED THE REPORTED PROBLEM COULD BE REPEATED AND THE TABLE DRIFTED INTO TREND AT A RATE OF 1.5 DEGREES EVERY 5 MINUTES WHICH CONFIRMED FAILURE. THE ACTUAL TABLE HAS SINCE BEEN RETURNED TO BERCHTOLD (B)(4) (MFR) FOR FURTHER EVALUATION WITH (B)(4). BERCHTOLD (B)(4) HAS ASKED (B)(4) TO SUPPLY A FULL 8-D REPORT. THIS REPORT SHALL LIST ANY ADDITIONAL FINDINGS AND REMEDIAL ACTION THAT MIGHT BE REQUIRED. THIS REPORT WILL ALSO BE FORWARDED TO BERCHTOLD CORP.

    Description of Event or Problem · 1

    EVENT DESCRIPTION AS RECORDED BY (B)(6) HOSP: TABLE WENT INTO "TREND" DURING PROCEDURE. REPORTED FAILURE COULD NOT BE DUPLICATED, HOWEVER, TABLE CPU WAS EXCHANGED AND TESTED BY BERCHTOLD TECHNICIAN. TABLE LATER REPEATED FAILURE ON (B)(6) 2009. NO INJURIES REPORTED. NO FURTHER DETAILS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BERCHTOLD SURGICAL TABLES OPERON SURGICAL TABLE FQO BERCHTOLD GMBH D850

    Patients

    Seq Age Sex Outcome Treatment
    1 Other