BEUDAMED
    FDA Adverse Event Death Summary report: N

    ANGIOMAT 6000

    MDR report key: 2288385 · Received October 4, 2011

    Report

    Report Number
    1518293-2011-00172
    Event Type
    Death
    Date Received
    October 4, 2011
    Report Date
    September 9, 2011
    Manufacturer
    LIEBEL-FLARSHEIM CO.
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011: COVIDIEN WAS NOTIFIED VIA E-MAIL FROM PHILIPS HEALTHCARE THAT THEY WERE INFORMED THAT A PT DIED AFTER INJECTION OF AIR BY AN INJECTOR. INFO WAS RECEIVED ON (B)(6), VIA AN EXTERNAL SOURCE, INDEPENDENT OF THE HOSPITAL AND UNRELATED TO PHILIPS WHICH LEADS PHILIPS TO THE CONCLUSION THAT AN ADVERSE EVENT INCIDENT HAS OCCURRED EARLIER AT A SITE WHERE OUR ENGINEER, APPARENTLY, SHORTLY AFTER THE INCIDENT OCCURRED WAS REQUESTED TO CHECK THE FUNCTIONALITY OF THE INJECTOR CONNECTED TO ONE OF OUR X-RAY SYSTEMS. PT OUTCOME: PT DIED AT ANOTHER HOSPITAL, WHERE HE WAS TRANSFERRED, APPARENTLY AFTER THE INCIDENT OF INJECTING AIR VIA THE INJECTOR. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOMAT 6000 ANGIOGRAPHIC POWER INJECTOR DXT LIEBEL-FLARSHEIM CO. ANGIO6000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death