BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGNETIC RESONANCE IMAGING SYSTEM

    MDR report key: 3890 · Received February 19, 1993

    Report

    Report Number
    3890
    Event Type
    Injury
    Date Received
    February 19, 1993
    Date of Event
    August 5, 1992
    Report Date
    December 18, 1992
    Manufacturer
    PHILIPS MEDICAL SYSTEMS, INC.
    Product Code
    LNH
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING MRI SCANNING OF LT. KNEE FOR PAIN. PATIENT HAD RT. KNEE REPLACEMENT DONE ON 7/14/92. DURING SCAN, PATIENT STATED KNEE WAS GETTING VERY HOT. PATIENT WAS REMOVED FROM SCANNER AND HEAT SUBSIDED, BUT HER KNEE DID FEEL HOT AT FRIST WHEN SHE WAS TAKEN OUT OF SCANNER. APTIENT WAS CRYING WHEN SHE CAME OUT OF SCANNER, BUT SHE FELT FINE AFTER A SHORT WHILE.THIS WAS PREVIOUSLY ACKNOWLEDGE TO GEORGE SILVER WITH PHILIPS MEDICAL SYSTEMS.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAGNETIC RESONANCE IMAGING SYSTEM MRI LNH PHILIPS MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention