BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTIGAS MONITOR

    MDR report key: 1273835 · Received December 26, 2008

    Report

    Report Number
    2520313-2008-00023
    Event Type
    Other
    Date Received
    December 26, 2008
    Date of Event
    November 26, 2008
    Report Date
    December 26, 2008
    Manufacturer
    MEDRAD, INC.
    Product Code
    CCK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDRAD SERVICE WENT TO THE SITE AND FOUND ALL EQUIPMENT TO BE IN WORKING ORDER. SERVICE REPLACED THE OXIMETER PROBE AND THE OXIMETER EXTENSION CABLE. THERE WAS MODEST DAMAGE TO THE OXIMETER EXTENSION CABLE. THE EXTENSION CABLE WAS RETURNED TO MEDRAD FOR EVALUATION. MEDRAD QUALITY ASSURANCE AND PRODUCT DEVELOPMENT ENGINEERING EVALUATED THE RETURNED CABLE WHICH SHOWED MELTED OUTER INSULATION THAT APPEARED TO ORIGINATE FROM OUTSIDE OF THE CABLE. THE INTERNAL WIRING OF THE CABLE DOES NOT APPEAR DAMAGED, INDICATING THAT THE FIRE WAS NOT LIKELY DUE TO AN OVER-CURRENT CONDITION OR SHORT CIRCUIT INTERNAL TO THE CABLE ITSELF. THE VERIS MONITOR DESIGN PROVIDES OVER-CURRENT PROTECTION ON ALL SIGNALS CARRIED BY THE OXIMETER EXTENSION CABLE, PREVENTING HEATING IF A SHORT CIRCUIT WERE TO OCCUR WITHIN THE CABLE. BASED ON THE INFORMATION, WE HAVE RECEIVED FROM MEDRAD SERVICE AND THROUGH MULTIPLE CONVERSATIONS WITH THE CUSTOMER, AND THE TYPE OF DAMAGE TO THE SPO2 EXTENSION CABLE (LIKELY THE RESULT, NOT THE CAUSE OF THE FIRE), WE HAVE DETERMINED THE FIRE WAS MOST LIKELY IGNITED DUE TO ARCING NEAR THE PAPER COVERING OF THE ELECTRODE PACKAGES. SUCH AN ARCING SITUATION COULD BE CREATED BY AN UNINTENDED RADIO-FREQUENCY (RF) COUPLING MECHANISM COMPRISED OF THE FOIL-LINED ELECTRODE PACKETS, AND ONE OR BOTH NEARBY MONITOR ELECTRICAL CABLES (THE OXIMETER EXTENSION CABLE AND THE COILED DC POWER CABLE). IT IS LIKELY THAT THE FOIL-LINED ELECTRODE PACKAGES WERE IN CLOSE PROXIMITY OR CONTACT WITH BOTH THE OXIMETER EXTENSION CABLE AND THE DC POWER CABLE. THE OXIMETER EXTENSION CABLE AND THE DC POWER CABLE WERE ALSO LIKELY IN CONTACT WITH ONE ANOTHER. THE ARRANGEMENT OF THESE COMPONENTS APPEARS TO HAVE EFFECTIVELY FORMED AN RF ANTENNA WHICH COUPLED AND AMPLIFIED ENERGY EMITTED BY THE IMAGING SYSTEM. ELECTRICAL POTENTIALS ACCUMULATED BETWEEN THE CABLE(S) AND THE ELECTRODE PACKETS, RESULTING IN ARCING. THIS ARCING CAUSED THE PAPER COVERING ON THE ELECTRODE PACKETS TO IGNITE. THIS IS AN ISOLATED INCIDENT ACROSS THE 1000+ SYSTEMS THAT HAVE BEEN INSTALLED AND USED DURING THE PAST 3.5 YEARS. THIS EVENT APPEARS TO BE THE RESULT OF A CONFLUENCE OF THREE INDEPENDENT ROOT CAUSES, WHICH EXPLAINS THE RARITY OF THIS ISSUE.

    Description of Event or Problem · 1

    AN OUTPATIENT WAS SCHEDULED FOR AN MRI OF THE LUMBAR SPINE AND HIPS. THE PATIENT WAS SEDATED FOR CLAUSTROPHOBIA AND WAS ONLY ATTACHED TO THE SPO2 FUNCTION OF THE MONITORING SYSTEM. THE TECHNOLOGIST HAD FINISHED THE LUMBAR SPINE MRI AND HAD JUST BEGUN THE HIP MRI WHEN HE NOTICED A SMALL FIRE THROUGH THE CONSOLE WINDOW. HE THEN WENT INTO THE ROOM AND BLEW OUT THE FLAMES. HE TURNED OFF THE MONITOR, UNPLUGGED IT FROM THE WALL, AND PROCEEDED TO FINISH THE PATIENT'S MRI. HE NOTED THAT SEVERAL ECG PACKETS HAD CAUGHT ON FIRE (THESE ECG ELECTRODES WERE MR-SAFE ELECTRODES). THERE WERE MINIMAL BURN MARKS ON THE SPO2 EXTENSION CABLE. THE ECG PACKETS WERE BEING STORED IN A POCKET ON THE TRAY OF THE MONITORING SYSTEM. THE SPO2 EXTENSION CABLE WAS LOCATED NEAR THE ECG PACKETS. THERE WAS NO INJURY TO THE PATIENT OR THE STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIGAS MONITOR MULTIGAS MONITOR CCK MEDRAD, INC. VERIS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR