BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 2000

    MDR report key: 1745893 · Received February 8, 2010

    Report

    Report Number
    9611343-2010-00005
    Event Type
    Death
    Date Received
    February 8, 2010
    Date of Event
    January 10, 2010
    Report Date
    February 8, 2010
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    MQB
    PMA / PMN Number
    K022322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER UF REPORT #(B) (4): "A (B) (6) MALE WITH SEVERE CORONARY ARTERY DISEASE AND PREVIOUS STINTS PRESENTED WITH AN ACUTE MYOCARDIAL INFARCTION. HE WAS TAKEN TO THE CARDIAC CATH UNIT FOR EMERGENT CATH WITH POSSIBLE PTCA. THE PT HAD KNOWN COMPLETE BLOCKAGE OF THE RCA, SO THE CARDIOLOGIST HAD THE GUIDE WIRE DOWN THE LEFT AND WAS PREPARING TO DO PTCA WHEN THE IMAGING EQUIPMENT FAILED. PRIOR TO THIS HAPPENING THE PT HAD REQUIRED THE PLACEMENT OF IABP AND PACEMAKER FOR THE CARDIOGENIC SHOCK. ATTEMPTS WERE MADE TO RE-BOOT THE SYS WITHOUT SUCCESS AND THE DECISION WAS MADE TO MOVE THE PT TO THE IMMEDIATELY ADJACENT CATH LAB #2. THE PT WAS AWAKE AND ALERT DURING THIS TRANSFER AND IABP WAS IN USE DURING THE TRANSFER. SHORTLY AFTER ARRIVAL TO LAB# 2 THE PT BECAME BRADYCARDIC AND LESS RESPONSIVE WHICH QUICKLY PROGRESSED TO ASYSTOLE. DESPITE AGGRESSIVE ACLS PROTOCOL MGMT THE PT EXPIRED." GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS STILL ONGOING. A FOLLOW-UP REPORT WILL BE ISSUED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INNOVA 2000 VASCULAR X-RAY SYSTEM MQB GE MEDICAL SYSTEMS SCS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death