BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECESS

    MDR report key: 1170282 · Received September 10, 2008

    Report

    Report Number
    1170282
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    July 8, 2008
    Report Date
    September 10, 2008
    Manufacturer
    INVIVO CORP.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERGOING MRI UNDER GENERAL ANESTHESIA WITH ROUTINE MONITORING. AT THE ONSET OF THE SCAN, THE ECG AND OXYGEN SATURATION WAVEFORM OF THE INVIVO PRECESS REMOTE MONITOR WAS LOST. THE SCAN WAS STOPPED. THE MRI TECH AND BIOMED TECH TRIED TO TROUBLESHOOT THE UNIT, BUT THE PROBLEM WAS NOT RESOLVED. THE INVIVO REPRESENTATIVE SUGGESTED A CHANGE IN THE FILTER SETTING AND THIS WORKED AND THE CASE RESUMED. THE PATIENT EXPERIENCED AN EXTRA 30 MINUTES OF GENERAL ANESTHESIA WHILE TROUBLESHOOTING OF THE DEVICE TOOK PLACE. THERE WERE NO ANESTHETIC-COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECESS MONITOR, PHYSIOLOGIC MHX INVIVO CORP. 3160DCU *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR