BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERCHTOLD SURGICAL TABLES

    MDR report key: 1520851 · Received October 29, 2009

    Report

    Report Number
    1220685-2009-00001
    Event Type
    Malfunction
    Date Received
    October 29, 2009
    Date of Event
    September 29, 2009
    Report Date
    October 13, 2009
    Manufacturer
    BERCHTOLD CORP.
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ACTUAL DEVICE INVOLVED IN REPORTED INCIDENT WAS ELEVATED BY A BERCHTOLD SERVICE TECHNICIAN ON 09/30/2009; HOWEVER, THE ORIGINAL TREND HYDRAULIC HOSES INVOLVED IN THE INCIDENT COULD NOT BE PRODUCED AND HAD BEEN DISCARDED BY THE HOSPITAL. TECHNICIAN WAS UNABLE TO CONFIRM HOSPITAL ASSUMPTION THAT THE TREND A AND B HOSES HAD BEEN WORN DUE TO THE FRICTION MOTION ACROSS THE CPU BRACKET. HOSPITAL INVESTIGATION INCLUDED THE EVAL OF 3 ADDITIONAL B810 TABLES IN INVENTORY OF THE SAME MODEL AND SIMILAR MFG DATE. THIS INFO WAS SHARED WITH THE LOCAL BERCHTOLD TECHNICIAN, AS WELL AS THE BERCHTOLD TEAM THAT TRAVELED TO THE FACILITY. THE ADDITIONAL THREE TABLE'S TREND HYDRAULIC HOSES DID SOW SIMILAR WEAR. BERCHTOLD'S INTERNAL INVESTIGATION SHOWED THAT A CPU BRACKET REVISION CHANGE WAS MADE BY THE SUB-SUPPLIER (HOERBIGER MICROFLUIDS) ON SEPTEMBER 9/28/2004. THIS REVISION INCORPORATED THE ADDITION OF A MITERED FLANGE TO THE BRACKET DUE TO A SUB-SUPPLIER REDESIGN OF THE PURCHASED HYDRAULIC LIFT COLUMN. THIS CHANGE WAS A RESULT OF HOERBIGER DISCONTINUING THE PRODUCTION OF THE INITIAL HYDRAULIC LIFT COLUMN. CORRECTIVE/PREVENTIVE ACTION: A BERCHTOLD TECHNICIAN HELPED THE HOSPITAL REPLACED THE TREND HOSES ON THE TABLE IN THE REPORTED INCIDENT AS WELL AS THE CPU BRACKET TO THE NEWER REVISION. DUE TO THE WEAR ON THE 3 ADDITIONAL TABLES, THE HOSES AND BRACKETS WERE ALSO PROACTIVELY CHANGED. TO DATE, BERCHTOLD HAS HAD NO OTHER REPORTED FAILURE ON THIS SERIES OF B810 SURGICAL TABLE AS A RESULT OF EXCESSIVE WEAR TO THE TREND HOSE DUE TO THE CPU BRACKET. BERCHTOLD DOES, HOWEVER, LIST THE FLEXIBLE HYDRAULIC HOSES AS PART OF THE RECOMMENDED MAINTENANCE SCHEDULE IN THE OPERON B810 SURGICAL TABLE INSTALL AND OPERATOR MANUAL (TABLE 5-1). HOSES SHOULD BE EVALUATED ANNUALLY. AS PART OF THIS CAPA, BERCHTOLD PLANS TO FURTHER EVALUATE ADDITIONAL TABLES IN THE FIELD OF THE SAME MODEL AND SIMILAR MFG DATE. RESULTS WILL BE EVALUATED AND FILED WITHIN THE INTERNAL INVESTIGATION DOCUMENTS INCLUDING ANY FIELD CORRECTIVE ACTION.

    Description of Event or Problem · 1

    EVENT DESCRIPTION AS RECORDED BY (B)(6) MEDICAL CENTER: HOSPITAL BIOMED STAFF CONTACTED BERCHTOLD'S TECHNICAL SERVICE HOTLINE REQUESTING REPLACEMENT HOSES FOR A B810 TABLE. THE BIOMED STAFF FOLLOWED UP WITH AN EMAIL REQUEST AND PICTURES OF A B810 SURGICAL TABLE IN FULL TREND, AS WELL AS DETAILED PICTURES OF TWO CUT TREND HOSES. ONE HOUR LATER, BERCHTOLD SALES WAS CONTACTED BY THE HOSPITAL DIRECTOR OF PERIOPERATIVE SERVICE STATING THAT A B810 TABLE HAD FAILED DURING A CASE AND THE PT HAD TO BE REMOVED. NO INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other