BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET OR TABLE SYSTEM MAGNUS

    MDR report key: 4921048 · Received July 15, 2015

    Report

    Report Number
    8010652-2015-00014
    Event Type
    Malfunction
    Date Received
    July 15, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 18, 2015
    Manufacturer
    MAQUET GMBH
    Product Code
    FQO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A MAQUET FIELD SERVICE TECHNICIAN (FST) VISITED THE HOSPITAL AND FOUND THAT A PRINTED CIRCUIT BOARD BUILT-IN THE UPPER PART OF THE COLUMN WAS CHARRED. THE DEVICE HAS BEEN SENT TO THE MANUFACTURER FOR FURTHER INVESTIGATION. THE ROOT CAUSE FOR THE EVENT COULD NOT BE CLEARLY DETERMINED. IN GENERAL TWO DIFFERENT ISSUES CAN CAUSE THE REPORTED EVENT: INGRESS OF LIQUIDS: THIS ROOT CAUSE CANNOT BE EXCLUDED BUT NO SIGNIFICANT MARKS COULD BE FOUND. SHORT-CIRCUIT: THE SERVICE TECHNICIAN FOUND SQUEEZING MARKS ON SOME WIRES CAUSED BY WRONG LAYING OF CABLES. POSSIBLY THIS LED TO SHORT-CIRCUITS. IT IS UNLIKELY THAT THIS OCCURRED DURING MANUFACTURING OF THE DEVICE BECAUSE A DIELECTRIC TEST IS PERFORMED FOR EACH DEVICE AFTER MANUFACTURING. ON THE OTHER HAND ACCORDING TO THE DHR OF THE AFFECTED DEVICE NO REPAIRS ON THIS PART OF THE COLUMN HAS BEEN PERFORMED BY MAQUET. MAQUET (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    AFTER A SURGICAL PROCEDURE SMELL OF BURNING ON THE OR TABLE COLUMN WAS NOTICED. NO INJURY REPORTED TO MAQUET. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460644 MAQUET OR TABLE SYSTEM MAGNUS TABLE, OPERATING-ROOM, AC-POWERED FQO MAQUET GMBH 1180.01A0

    Patients

    Seq Age Sex Outcome Treatment
    1