BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAGNUS CARB.-FIBRE TABLE TOP, LONG BOLUS

    MDR report key: 11504233 · Received March 17, 2021

    Report

    Report Number
    8010652-2021-00012
    Event Type
    Death
    Date Received
    March 17, 2021
    Date of Event
    March 5, 2021
    Report Date
    July 6, 2021
    Manufacturer
    HOLGER ULLRICH
    Product Code
    KXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    A GETINGE-MAQUET FIELD SERVICE ENGINEER HAS VISITED THE CLINIC AND INVESTIGATED THE PRODUCTS. NO DAMAGE OR MALFUNCTION WAS FOUND ON THE TABLE TOP OR THE TABLE COLUMN. THE USED OR TABLE TOP 118016A2 CAN BE MOVED RELATIVE TO THE OR TABLE COLUMN IN THE LONGITUDINAL DIRECTION. ACCORDING TO THIS LONGITUDINAL SHIFT, THERE MIGHT BE SOME PLAY. THIS PLAY MAKES THE CARDIOPULMONARY RESUSCITATION (CPR) MORE DIFFICULT. IN THE INSTRUCTIONS FOR USE (IFU) THE USER IS ADVISED TO ADJUST THE LONGITUDINAL SHIFT OF THE TABLE TOP, IF NECESSARY. A WAY TO MINIMIZE THE PLAY IS TO CENTER THE 118016A2 TABLE TOP OVER THE COLUMN. ACCORDING TO THE CLINIC, THE TABLE TOP WAS NOT CENTERED ABOVE THE COLUMN, BUT 3/4 THE WAY TOWARDS THE HEAD END. THE CLINIC WAS FAMILIAR WITH THE FACT THAT THE TABLE TOP CAN BE CENTERED ABOVE THE COLUMN TO MINIMIZE THE PLAY AND RELATIVE MOVEMENT OF THE TABLE TOP. IT IS POSSIBLE TO PERFORM A CPR IN ANY POSITION WITHOUT THE RISK OF MATERIAL FAILURE. NO DAMAGE OR MALFUNCTION WAS FOUND ON THE TABLE TOP OR THE TABLES COLUMN. BASED ON THE INVESTIGATION WE CONCLUDE THAT NO MALFUNCTION OR DAMAGE OF THE TABLE HAS CONTRIBUTED TO THE OUTCOME OF THE CPR. CONCERNING THE CODE 4581 FOR "HEALTH EFFECTS - CLINICAL SIGNS AND SYMPTOMS OR CONDITIONS" WE WOULD LIKE TO ADD THE FOLLOWING: A CARDIOPULMONARY RESUSCITATION (CPR) WAS NOT SUCCESSFUL AND THE PATIENT DIED. WE DO NOT KNOW WHY THE CPR WAS REQUIRED IN THE FIRST PLACE. GETINGE-MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 0

    MANUFACTURER REFERENCE# (B)(4).

    Additional Manufacturer Narrative · 1

    A GETINGE-MAQUET FIELD SERVICE ENGINEER HAS VISITED THE CLINIC AND INVESTIGATED THE PRODUCTS. NO DAMAGE OR MALFUNCTION WAS FOUND ON THE TABLE TOP OR THE TABLES COLUMN. WE ARE IN CONTACT WITH THE CLINIC TO EVALUATE AND INVESTIGATE ALL ASPECTS THAT MIGHT HAVE CONTRIBUTED TO THE OUTCOME OF THE CPR. THE USED COLUMN IS 118001B1, SERIAL# (B)(4), HYBRID OR TABLE COLUMN, SURFACE-MOUNTED. AT TIME OF THIS REPORT THE INVESTIGATION IS STILL ONGOING. WHEN THE INVESTIGATION IS COMPLETE THE REPORT WILL BE UPDATED AND A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO US. A CARDIOPULMONARY RESUSCITATION (CPR) WAS PERFORMED ON THE OPERATING ROOM TABLE TOP 1180.16A2 WHICH WAS MOUNTED ON THE OPERATING ROOM TABLE COLUMN 118001B1. THE CPR WAS NOT SUCCESSFUL AND THE PATIENT DIED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402551 MAGNUS CARB.-FIBRE TABLE TOP, LONG BOLUS TABLE, RADIOLOGIC KXJ HOLGER ULLRICH 118016A2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death USED COLUMN: 118001B1, SERIAL# (B)(6)| USED COLUMN: 118001B1, SERIAL# (B)(4)