BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORATION

    MDR report key: 1550319 · Received December 2, 2009

    Report

    Report Number
    1051786-2009-00015
    Event Type
    Injury
    Date Received
    December 2, 2009
    Report Date
    February 26, 2009
    Manufacturer
    INVIVO CORPORATION
    Product Code
    MWI
    PMA / PMN Number
    K053462
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER REPORTED THAT THE DEVICE LOST COMMUNICATION DURING A CASE. LATER IN THE SAME CASE, THE PT CODED AND WAS SUCCESSFULLY REVIVED. THE USER REPORTED THAT THE COMMUNICATION MALFUNCTION WAS UNRELATED TO THE EVENT WITH THE PT. A COMMUNICATION PROBLEM REPORTEDLY OCCURRED AND WAS RESOLVED PRIOR TO THE PT CODE. THEREFORE, THE REPORTED COMMUNICATION PROBLEM DID NOT CAUSE OR CONTRIBUTE TO THE OUTCOME OF THE PT. THE DEVICE CORRECTLY ALERTED THE STAFF TO THE DETERIORATION IN THE PT'S CONDITION. AS A RESULT, THE STAFF WAS ABLE TO ACT PROMPTLY AND THERE WAS NO DELAY IN TREATMENT OF THE PT. THERE HAS BEEN NO LASTING ADVERSE IMPACT TO THE PT REPORTED. A COMMUNICATION MALFUNCTION IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY BECAUSE IT IS A MALFUNCTION THAT WOULD BE OBVIOUS TO THE USER. THIS MALFUNCTION WOULD BE OBVIOUS TO THE USER DUE TO THE NUMEROUS INDICATORS GIVEN BY THE SYSTEM, SUCH AS: ON THE FRONT OF THE DISPLAY UNIT, THERE IS A TRI-COLORED LED WHICH INDICATES THE AC/BATTERY POWER CONDITION OF THE MONITOR, ALONG WITH AN INDICATION OF WHETHER OR NOT THE SYSTEM IS COMMUNICATING. IF THE SYSTEM IS NOT COMMUNICATING, THE LED WILL BE FAST BLINKING. IF THE SYSTEM IS COMMUNICATING, THE LED WILL REMAIN SOLID. THE DISPLAY UNIT ALSO DISPLAYS THE COMMUNICATION STATUS OF EACH COMPONENT OF THE SYSTEM. IF A COMPONENT'S SYMBOL HAS AN "X" THROUGH IT, THIS INDICATES A PROBLEM WITH THE COMMUNICATION OF THAT COMPONENT. THE INDIVIDUAL WIRELESS MODULES HAVE A LED THAT, WHEN BLINKING, INDICATE A PROBLEM WITH THAT MODULE'S COMMUNICATION TO THE PROCESSING UNIT. A COMMUNICATION PROBLEM WOULD ALSO BE OBVIOUS BY VIEWING THE WAVEFORMS BEING MONITORED. A COMMUNICATION PROBLEM WILL MANIFEST ITSELF AS A BREAK IN THE WAVEFORM. AS A RESULT, THE WAVEFORM WILL NOT BE CONTINUOUS, BUT WILL HAVE GAPS. THE DEVICE MFR FOLLOWED-UP WITH THE USER AND THE USER REPORTED THAT THEY WERE NOT EXPERIENCING ANY ADDITIONAL COMMUNICATION PROBLEMS WITH THE DEVICE AND DID NOT REQUIRE ANY ADDITIONAL ASSISTANCE FROM THE DEVICE MFR. THE LIMITED AVAILABLE INFO DOES NOT IDENTIFY A CAUSE FOR THE LOST COMMUNICATION. NO ADDITIONAL ACTIONS BY THE DEVICE MFR ARE PLANNED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO THE DEVICE MFR THAT THE DEVICE LOST COMMUNICATION DURING A DIFFUSION SCAN AND, AS A RESULT, THE PT WAS PULLED OUT OF MRI BORE AND ECG LEADS AND SPO2 FINGER PROBE WERE REMOVED AND THEN REATTACHED TO PT. THE USER CLAIMED THAT APPROXIMATELY 10 MINS LATER, THE PT'S SPO2 DROPPED TO ALARMING LEVELS. THE USER STATED THAT THE PT WAS PULLED OUT OF THE MRI BORE AND WAS BLUE. THE PT WAS BAGGED AND RESUSCITATED. THE USER ALSO REPORTED THAT THE ECG PARAMETER WAS ACTING ERRATICALLY DURING THE CASE. REFER TO MDR 1051786-2009-00016.

    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 21 DA Required Intervention