BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORATION

    MDR report key: 1534698 · Received November 18, 2009

    Report

    Report Number
    1051786-2009-00013
    Event Type
    Injury
    Date Received
    November 18, 2009
    Report Date
    November 24, 2008
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER CALLED THE DEVICE MANUFACTURER AND WANTED TO KNOW WHETHER OR NOT THE ETCO2 SET-UP THEY WERE USING WITH THE PATIENT WAS ADEQUATE FOR USE WITH THE DEVICE. THE USER FAXED IN A DIAGRAM OF THEIR SET-UP FOR ETCO2 TO THE DEVICE MANUFACTURER. THE DEVICE MANUFACTURER DETERMINED THAT THE USER'S SET-UP WAS APPROPRIATE FOR ETCO2 AND WOULD HAVE WORKED WITH THE DEVICE. AFTER NUMEROUS DISCUSSION WITH THE USER, IT WAS DETERMINED THAT THE EVENT WAS CAUSED BY AN INSUFFICIENT AMOUNT OF O2 BEING ADMINISTERED TO THE PATIENT BY THE CLINICAL STAFF AND THAT THE DEVICE DID NOT MALFUNCTION. ACCORDING TO THE USER FACILITY'S BIOMEDICAL ENGINEER, THE STAFF DID NOT HAVE A MEANS OF DETERMINING THE O2 FLOW TO THE PATIENT AS THEY DID NOT HAVE A FLOW METER ON THE CIRCUIT. ACCORDING TO THE BIOMEDICAL ENGINEER, THE STAFF WAS "GUESSING BASED ON THE FULLNESS OF THE BAG". MONITORING OF THE PATIENT WAS NOT A NEGATIVE FACTOR IN THE SERIOUS INJURY OR THE OUTCOME OF THE PATIENT. THE DEVICE DID NOT MALFUNCTION AND CORRECTLY ALERTED THE STAFF TO THE DETERIORATION IN THE PATIENT'S CONDITION. AS A RESULT, THE STAFF WAS ABLE TO ACT PROMPTLY AND THERE WAS NO DELAY IN TREATMENT OF THE PATIENT. THERE HAS BEEN NO LASTING ADVERSE IMPACT TO THE PATIENT REPORTED. AS STATED ABOVE, THE DEVICE MANUFACTURER HELD NUMEROUS DISCUSSIONS WITH THE USER REGARDING THEIR ETCO2 SET-UP. THE USER CANCELED THE LAST SCHEDULED CONFERENCE CALL IN 2008 BECAUSE THE USER FACILITY HAD NOT BEEN ABLE TO RE-GROUP TO DISCUSS THE OUTCOME OF THE PREVIOUS CONFERENCE CALL. ACCORDINGLY, THE BIOMEDICAL ENGINEER STATED THAT THEY WOULD CONTACT THE DEVICE MANUFACTURER SHOULD THEY REQUIRE ANY ADDITIONAL ASSISTANCE IN THE FUTURE. TO DATE, THE DEVICE MANUFACTURER HAS NOT RECEIVED ANY ADDITIONAL CALLS FROM THIS USER REGARDING THIS EVENT. NO ADDITIONAL ACTIONS BY THE DEVICE MANUFACTURER ARE PLANNED.

    Description of Event or Problem · 1

    THE USER REPORTED THAT THEY WERE MONITORING A PATIENT AND THE PATIENT CODED. PATIENT WAS REVIVED, AND WAS IN STABLE CONDITION. THE USER HAD QUESTIONS FOR THE DEVICE MANUFACTURER ABOUT THE WAY THEY HAD THE MONITOR SET-UP FOR ETCO2 MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION PRECESS MRI PATIENT MONITORING SYSTEM MWI INVIVO CORPORATION 3160

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention