BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVIVO CORPORATION

    MDR report key: 1550320 · Received December 2, 2009

    Report

    Report Number
    1051786-2009-00016
    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 ECG WAS ACTING ERRATICALLY DURING A DIFFUSION SCAN. ALTERNATIVE MONITORING WAS IMPLEMENTED BY THE USER (OBTAINING HEART RATE FROM SPO2, INSTEAD OF ECG). 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. IF THIS MALFUNCTION WERE TO RECUR, IT WOULD NOT LEAD TO A SERIOUS INJURY OR DEATH BECAUSE ERRATIC ECG READINGS ARE NOT DIFFICULT TO DETECT. ERRATIC ECG READINGS PRODUCE A NOISY, NON-PHYSIOLOGICAL ECG WAVEFORM. THIS TYPE OF WAVEFORM WOULD BE OBVIOUS TO A TRAINED CLINICIAN. THE DEVICE'S LABELING (INSTRUCTIONS FOR USE) PROVIDES GUIDANCE TO THE USER ON HOW TO OBTAIN A GOOD ECG SIGNAL. ALSO, THE DEVICE PROVIDES THE USER WITH AN ECG SCALE INDICATOR ON THE DEVICE'S DISPLAY, WHICH TELLS THE USER THE HEIGHT THE PT'S ECG TRACE SHOULD BE IN ORDER TO MINIMIZE MRI GRADIENT INTERFERENCE ON THE ECG WAVEFORM. THEREFORE, THE REPORTED SYMPTOM REPRESENTS MINIMAL HEALTH RISK. THE DEVICE MFR CONDUCTED AN IN-SERVICE OVERVIEW, PER THE INSTRUCTIONS FOR USE, FOR THE USER FACILITY'S ANESTHESIA AND MRI STAFF. THE TRAINING FOCUSED ON ECG PERFORMANCE DURING DIFFUSION SCANS, AS WAS THE SITUATION IN THIS EVENT. SPECIFICALLY, PROPER PREPARATION OF THE PT AND PROPER PLACEMENT OF THE ECG ELECTRODES ON THE PT WAS COVERED. ADDITIONALLY, THE USER WAS ADVISED OF THE NEED TO CONFIRM A GOOD ECG SIGNAL PRIOR TO PUTTING PT IN BORE. THE USER HAS INDICATED THAT THIS TRAINING HAS HELPED IMPROVED THE PERFORMANCE OF ECG AT THE USER FACILITY, BUT HAS NOT RESOLVED ALL PROBLEMS WITH ECG DURING DIFFUSION SCANS. DIFFUSION SCANS ARE A RECENTLY-EVOLVING MRI MODALITY AND THEY CONSIST OF VERY FAST AND AGGRESSIVE GRADIENTS, WHICH SATURATE ANY MRI PT MONITOR'S ECG FILTERS. AS A RESULT, USERS OF PT MONITORS IN THE MRI ENVIRONMENT MAY EXPERIENCE ERRATIC ECG PERFORMANCE WHILE CONDUCTING THIS TYPE OF SCAN. THE DEVICE MFR IS CONSIDERING ADDITIONAL LABELING IN THE INSTRUCTIONS FOR USE WHICH WILL FURTHER ADVISE USERS OF THE EFFECTS SOME MRI SYSTEMS CAN HAVE ON AN ECG WAVEFORM, DEPENDING ON THE TYPE OF SCAN BEING PERFORMED. THE ADDITIONAL VERBIAGE BEING CONSIDERED WILL ALSO SUGGEST STEPS THE USER CAN TAKE TO PREVENT THE LOSS OF ECG MONITORING DURING THE CASE, SUCH AS SWITCHING THE HR SOURCE FROM ECG TO SPO2.

    Description of Event or Problem · 1

    DURING A DIFFUSION SCAN, THE USER CLAIMED THAT 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 REPORTED THAT SPO2 WORKED PROPERLY DURING THE CASE, BUT THE ECG PARAMETER WAS ACTING ERRATICALLY. THE USER ALSO REPORTED THAT THERE WAS AN INTERMITTENT COMMUNICATION PROBLEM DURING THE CASE. REFER TO MDR 1051786-2009-00015.

    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