BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE MR MONITOR

    MDR report key: 439835 · Received January 23, 2003

    Report

    Report Number
    MW1027342
    Event Type
    Malfunction
    Date Received
    January 23, 2003
    Date of Event
    January 3, 2003
    Report Date
    January 8, 2003
    Manufacturer
    DATASCOPE CORP./PT MONITORING DIVISION
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3-21-2003: THE CUSTOMER REPORTED THAT WHILE THEY WERE MOVING THE MONITOR FROM THE FRONT OF THE MAGNET TO THE BACK OF THE MAGNET, THE MONITOR WAS ATTRACTED TO THE MAGNET AND FORCIBLY STUCK IT. NO PT WAS INVOLVED. THE UNIT WAS RETURNED TO DATASCOPE AND WAS REPAIRED. THE NIBP MODULE AND THE MEMORY BATTERY WERE REPLACED. THE UNIT WAS TESTED TO FACTORY SPECIFICATIONS AND RETURNED TO THE CUSTOMER. DATASCOPE DOES NOT ATTRIBUTE THE EVENTS DESCRIBED IN THE MEDICAL DEVICE REPORT TO THE MR MONITOR. A COMPANY REP VISITED THE SITE AND THE DETERMINED THAT THE CUSTOMER BROUGHT THE MONITOR TOO CLOSE TO THE MAGNET. THE MR OPERATING INSTRUCTIONS (PAGE VII) INSTRUCT THE USER THAT THE MR MONITOR MUST BE INSTALLED IN THE AREA AROUND THE MAGNET WHERE THE LEAKAGE MAGNETIC FIELD IS LESS THAN OR EQUAL TO 40 MT (400 G). AS A RESULT OF APPARENT USER ERROR, DATASCOPE CORP CONDUCTED A FOLLOW-UP IN-SERVICE TRAINING WITH THE CUSTOMER. THE DEVICE HAS BEEN RETURNED TO THE HOSPITAL. THE MR MONITOR IS MARKETED UNDER THE MAGLIFE C(K972535), A MULTIPARAMETER PT MONITOR WHICH IS INDICATED FOR MONITORING IN THE IMMEDIATE VICINITY OF A MAGNETIC RESONANCE IMAGER FOR THE SURVEILLANCE OF PTS UNDERGOING MRI EXAMINATIONS.

    Description of Event or Problem · 1

    AN MRI TECHNOLOGIST WAS PUSHING THE DATA-SCOPE MONITOR BEHIND THE MRI 1.5T UNIT AND AS HE PASSED THE MAGNET OPENING (APPROX. 1 FOOT AWAY FROM THE BORE), THE MAGNET PULLED THE MONITOR INTO THE BORE WHERE IT BECAME LODGED. THE MONITOR WAS SOLD TO THE HOSP AS AN MRI SAFE UNIT AND THE HOSP WAS NOT AWARE THAT IT CONTAINED FERROUS MATERIAL. FOLLOWING THE INCIDENT, DATASCOPE STATED THAT A POWER SUPPLY DEVICE IN THE MONITOR WAS FERROUS. THE BLOOD PRESSURE MONITORING CAPABILITY OF THIS MONITOR WAS DAMAGED AND THE MONITOR IS BEING RETURNED TO DATASCOPE FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE MR MONITOR CARDIAC/VITAL SIGNS MONITOR MHX DATASCOPE CORP./PT MONITORING DIVISION MR MONITOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other