BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORATION

    MDR report key: 1550328 · Received December 2, 2009

    Report

    Report Number
    1051786-2009-00020
    Event Type
    Injury
    Date Received
    December 2, 2009
    Date of Event
    October 27, 2009
    Report Date
    October 27, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MHX
    PMA / PMN Number
    K040915
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE USER, TESTS WERE PERFORMED BY THE USER FACILITY'S BIOMED DEPT ON SPO2 CABLE AND NOTHING WAS FOUND TO BE WRONG WITH IT, AND IT APPEARED TO BE WORKING FINE. THE USER RETURNED BOTH THE SPO2 CABLE AND FINGER GRIP TO THE DEVICE MANUFACTURER FOR ADDITIONAL EVALUATION. THE DEVICE MANUFACTURER VISUALLY EXAMINED BOTH THE SPO2 CABLE AND FINGER GRIP, AND THEY WERE FOUND TO BE NORMAL. THE FINGER GRIP WAS ALSO TURNED INSIDE OUT AND EXAMINED UNDER A MICROSCOPE. THERE WAS NO EVIDENCE OF SUBSTANCE(S) THAT WOULD HAVE CAUSED OR CONTRIBUTED TO A PT BURN, SUCH AS METAL FLAKES. THE SPO2 CABLE DID NOT SHOW EVIDENCE OF OVERHEATING, AND NO METAL PARTICLES/FLAKES WERE OBSERVED ON THE OUTSIDE OF THE FIBER OPTIC ENDS OR JACKET. BOTH THE SPO2 CABLE AND FINGER GRIP WERE TESTED USING THE SAME MODEL TYPE MONITOR AS THAT AT THE USER FACILITY. BOTH THE SPO2 CABLE AND FINGER GRIP FUNCTIONED AS EXPECTED DURING THIS TESTING. WHEN TESTED USING THE RETURNED SPO2 CABLE AND FINGER GRIP, THE PT MONITOR DISPLAYED A NORMAL SPO2 WAVEFORM WITH 96% O2 AND 78 BPM WITH A HUMAN FINGER INSERTED INTO THE FINGER GRIP. THE SPO2 WAVEFORM PRODUCED BY THE PT MONITOR WITH THE RETURNED CABLE AND FINGER GRIP WAS CLEAN, WITH NO NOTICEABLE ANOMALIES. THE DEVICE MANUFACTURER ASKED THE USER IF THEY THOUGHT THE ACTUAL PT MONITOR MALFUNCTIONED. THE USER STATED THAT THEY DID NOT THINK THE PT MONITOR MALFUNCTIONED AND THAT THEY WERE ONLY CONCERNED ABOUT THE SPO2 CABLE AND FINGER GRIP. THE DEVICE MANUFACTURER OFFERED TO SEND A FIELD SERVICE REP TO THE USER FACILITY TO EVALUATE THE PT MONITOR. TO DATE, THE DEVICE MANUFACTURER HAS NOT BEEN NOTIFIED OF THE USER FACILITY'S DESIRE TO HAVE THE PT MONITOR EVALUATED. PER THE USER, THEY CONTINUED TO USE THE PT MONITOR, THE SPO2 CABLE AND THE SPO2 FINGER GRIP THAT WERE IN USE DURING THE REPORTED INCIDENT, ON PTS AFTER THE REPORTED INCIDENT. THERE IS NO EVIDENCE THAT THE SPO2 CABLE AND FINGER GRIP CAUSED OR CONTRIBUTED TO THE PT'S INJURY GIVEN THE DEVICE MANUFACTURER'S EVALUATION OF THE RETURNED PRODUCT, ALONG WITH THE FACT THAT THE FIBER OPTIC CABLE AND FINGER GRIP ARE NONCONDUCTIVE. IT WAS REPORTED THAT ALL OF THE PT'S FINGERS (INCLUDING THE FINGER WHERE THE SPO2 FINGER SENSOR WAS POSITIONED) AND PART OF THE PT'S PALM WAS BURNED. THIS DESCRIPTION OF THE PT'S INJURY DOES NOT CORRELATE WITH ONE THAT WOULD HAVE BEEN CAUSED BY THE PT MONITOR OR AN ACCESSORY OF THE PT MONITOR, AND IS IN CONFLICT WITH THE INITIAL REPORT. THE DEVICE MANUFACTURER HAS REQUESTED COPIES OF PICTURES THAT ARE AVAILABLE OF THE PT'S INJURY. THE USER FACILITY'S RISK MANAGER HAS ADVISED THAT THE PT'S FAMILY IS NOT READY TO RELEASE PICTURES OF THE PT'S INJURY TO THE DEVICE MANUFACTURER. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFO IS PROVIDED BY THE USER FACILITY OR THE PT'S FAMILY, WHICH IMPACTS THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE DEVICE MANUFACTURER THAT A PT WAS UNDERGOING A HEAD AND CERVICAL SPINE MRI SCAN. AND THAT SPO2 WAS HOOKED UP FOR MONITORING. AFTER THE SCAN WAS COMPLETE, THE USER CLAIMED THAT THE PT IMMEDIATELY COMPLAINED OF BURNS ON THE HAND WHERE THE SPO2 FINGER GRIP WAS ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INVIVO CORPORATION MAGNITUDE MRI PATIENT MONITORING SYSTEM MHX INVIVO CORPORATION 3150M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention