BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET FIXTURE

    MDR report key: 5035263 · Received August 27, 2015

    Report

    Report Number
    8010652-2015-01002
    Event Type
    Malfunction
    Date Received
    August 27, 2015
    Date of Event
    July 29, 2015
    Report Date
    July 29, 2015
    Manufacturer
    KEHLER STRASSE 31
    Product Code
    FWZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). TO DETERMINE THE ROOT CAUSE OF THE BREAK THE BROKEN PART WAS SENT TO AN ACCREDITED TEST LABORATORY FOR FURTHER INVESTIGATION OF THE WELDING. PRESUMABLY FREQUENT OVERLOAD OR ROUGH HANDLING (E.G. BECAUSE OF COLLISIONS) LED TO THE BREAKAGE. THE BREAKAGE WAS PROMOTED BY A NOT OPTIMALLY EXECUTED WELD JOINT. ACCORDING TO THE TEST REPORT, THE FAILURE OF THE WELDED JOINT WAS DUE TO HOT CRACKS IN THE WELDED MATERIAL. THE HOT CRACKING WAS FAVORED BY A WIDE SEAM WIDTH IN RELATION TO THE SEAM DEPTH AND THEREBY HIGH SHRINKAGE STRESS DUE TO TRANSVERSE SHRINKAGE. IT CANNOT BE EXTRAPOLATED FROM THESE FINDINGS WHETHER THERE WERE FURTHER HOT CRACKING INFLUENCES SUCH AS CONTAMINATED WELD EDGES. MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURER IS AWAITING RETURN OF DEVICE IN ORDER TO PERFORM INVESTIGATIONS. REASON FOR BREAK AT THE MOMENT UNCLEAR. USUALLY MORE FREQUENT OVERLOADING OR ROUGH HANDLING LEAD TO BREAKAGES. MAQUET (B)(4)PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING PREPARATION FOR A SURGERY, THE FIXTURE (#1002.65A0) TO ADJUST THE HEAD REST TO THE OPERATING ROOM TABLE BROKE. NO PATIENT WAS INVOLVED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570117 MAQUET FIXTURE ACCESSORIES, OPERATING-ROOM, TABLE (KIT) FWZ KEHLER STRASSE 31 1002.65A0

    Patients

    Seq Age Sex Outcome Treatment
    1