BEUDAMED
    FDA Adverse Event Other Summary report: N

    ALLURA XPER FD10

    MDR report key: 597986 · Received May 3, 2005

    Report

    Report Number
    1217116-2005-00009
    Event Type
    Other
    Date Received
    May 3, 2005
    Date of Event
    March 21, 2005
    Report Date
    April 29, 2005
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    IZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    "EQUIPMENT BEGAN TO DISPLAY AN ALARM, "FLAT DETECTOR OVERHEATING, FINISH CASE, CALL SERVICE" (A SYSTEM WARNING MESSAGE). CATH LAB TEAM LEADER WAS NOTIFIED, WHO PLACED CALL TO PHILIPS MEDICAL SYSTEMS. TEAM LEAD TROUBLESHOT ALARM WITH RTAC SUPPORT TO DETERMINE REASON FOR ALARM. COOLANT LOW? NO, GAUGE READING INDICATED THAT THE TEMP. LEVEL WAS CLIMBING ON THE FLAT DETECTOR. TECHNICAL SUPPORT ADVISED THAT THE FLAT DETECTOR COOL AND PUMP WAS OUT AND IN NEED OF REPLACEMENT. TECH. SUPPORT ADVISED THAT THE PART WOULD BE ORDERED AND AVAILABLE THE NEXT DAY AT NOON. AT NO TIME DID TECH SUPPORT ADVISE THE TEAM LEAD THAT THE SYSTEM WOULD BECOME INOPERABLE. THE GE LAB THAT WAS REPLACED WOULD OVERHEAD ROUTINELY BUT REMAIN OPERABLE, SO STAFF WERE NOT CONCERNED THAT THE SYSTEM WOULD SHUT DOWN. INTERVENTIONAL CASED STARTED BY THE PHYSICIAN. ENGAGED RIGHT CORONARY ARTERY WITH THE GUIDING CATHETER, ONCE INSERTED, PT EXPRERIENCING CHEST PAIN, AGITATION, DIAPHORESIS AND MILDLY COMBATIVE. PT TREATED WITH MEDICATIONS. BALLOON INSERTED IN PRXIOMAL RIGHT CORONARY AND INFLATED FOR 30 SECONDS. FLOURO FIALED, SYSTEM REBOOTED AND CAME BACK UP FOR 30 SECONDS. SYSTEM FAILED AGAIN AND COMPLETELY SHUT DOWN. REMOVAL OF THE BALLOON, GUIDEWIRE, AND SHEATH SEWIN IN PLACE. PT STILL AGITIATED AND COMBATIVE REQUIRED 4-5 STAFF TO HOLD PT ON STRETCHER. PT TAKEN TO ICU."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLURA XPER FD10 ANGIOGRAPHIC X-RAY SYSTEM IZI PHILIPS MEDICAL SYSTEMS ALLURA XPER FD10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention