BEUDAMED
    FDA Adverse Event Death Summary report: N

    MAQUET UNIVERSAL FRAME

    MDR report key: 4787219 · Received May 19, 2015

    Report

    Report Number
    8010652-2015-00007
    Event Type
    Death
    Date Received
    May 19, 2015
    Date of Event
    March 20, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MAQUET GMBH
    Product Code
    FWZ
    Removal / Correction Number
    8010652-08/13/2015-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CHIEF PHYSICIAN REPORTED THE ALLEGED INCIDENT TO MAQUET. THE PHYSICIAN DID NOT STATE THAT THE DEVICE FAILED, OR THAT THE DEVICE CONTRIBUTED TO THE INCIDENT. THE PHYSICIAN INFORMED MAQUET THAT THEY WILL SUSPEND THE USE OF THE ADJUSTABLE POSITIONING ELEMENTS 1007.28A0 ON THE UNIVERSAL FRAME 1007.24A0. THE EVENT IS UNDER INVESTIGATION BY MAQUET. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFO IS AVAILABLE. MAQUET GMBH PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    MANY DIFFERENT PARAMETERS CONTRIBUTE TO THROMBOSIS AND TO THROMBOEMBOLIC EVENTS. FOR EXAMPLE THE FOLLOWING PARAMETERS ARE KNOWN TO HAVE AN INFLUENCE ON THROMBOEMBOLIC EVENTS IN GENERAL: DURATION OF THE SURGICAL PROCEDURE; PATIENT DISEASE; HEALTH STATUS OF THE PATIENT (CONCOMITANT MORBIDITY); PATIENT POSITIONING IN GENERAL (SUPINE POSITION AGAINST PRONE POSITION); WEIGHT AND AGE OF THE PATIENT; PROPHYLACTIC ANTITHROMBOTIC MEASURES (E.G. MEDICATION, SURGICAL STOCKING). THROMBOEMBOLIC EVENTS ARE KNOWN TO OCCUR IN ALL KINDS OF SURGERY WITHOUT ONE OR SEVERAL CLEARLY IDENTIFIED RISK FACTOR(S). THEREFORE AN INFORMED CONSENT WITHOUT MENTIONING THAT SUCH AN EVENT MAY OCCUR IS REGARDED TO BE INCOMPLETE. HOWEVER, SEVERAL TESTS WITH THE AFFECTED ADJUSTABLE POSITIONING ELEMENTS 1007.2BAC WERE PERFORMED TO DETERMINE WHETHER ALSO THE DEVICE ITSELF COULD HAVE PLAYED A ROLE. MEASURING THE VENOUS BACKFLOW BY DOPPLER SONOGRAPHY, PERFORMED BY TWO MEDICAL EXPERTS FROM OUTSIDE, OF DIFFERENT PERSONS POSITIONED ON THE ADJUSTABLE POSITIONING DEVICE REVEALED THAT THE HIP ELEMENTS NEGATIVELY AFFECT THE VENOUS BACKFLOW UNDER CERTAIN CONDITIONS AND THEREFORE MAY BE CONSIDERED AS A CONTRIBUTING FACTOR TO THROMBOEMBOLIC EVENTS.

    Description of Event or Problem · 1

    AFTER COMPLETION OF A LUMBAR SPINE SURGERY (DURATION OF THE PRODUCT ABOUT 5 HOURS), IN PRONE POSITION USING THE MAQUET UNIVERSAL FRAME 1007.24A0 TOGETHER WITH THE ADJUSTABLE POSITIONING ELEMENTS 1007.28A0 - WHEN THE PT WAS TRANSFERRED ONTO ANOTHER OPERATING ROOM TABLE TOP, ELECTROMECHANICAL DISSOCIATION (EMD) HAS BEEN DIAGNOSED. RESUSCITATION HAS BEEN PERFORMED WITHOUT SUCCESS. THE PHYSICIAN HAS REPORTED THAT THE EVENT MAY HAV E BEEN CAUSED BY A PULMONARY EMBOLISM. MANUFACTURER REFERENCE #2015-42432.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324063 MAQUET UNIVERSAL FRAME ACCESSORIES, OPERATING-ROOM, TABLE FWZ MAQUET GMBH 1007.24A0

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death