BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEVERAL DEVICES USED (SEE EXHIBIT A)

    MDR report key: 11697 · Received February 23, 1994

    Report

    Report Number
    11697
    Event Type
    Death
    Date Received
    February 23, 1994
    Date of Event
    December 8, 1993
    Report Date
    December 23, 1993
    Manufacturer
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS A CRITICALLY ILL PATIENT WHO DIED DURING AN MRI EXAMINATION. PRIOR TO THE EXAMINATION, A PULSE OXIMETER WAS PLACED ON PATIENT, BUT IT DID NOT PROVIDE ANY READINGS. DURING THE MRI, THE PATIENT WAS CONNECTED TO AN MRI-COMPATABLE MECHANICAL VENTILATOR. WHEN REMOVED FROM THE MRI MACHINE PATIENT WAS PULSELESS. INITIAL REVIEW DID NOT SUGGEST THAT HIS DEATH WAS OTHER THAN THE EXPECTED DEATH OF AN EXTREMELY ILL PATIENT. SUBSEQUENT REVIEW SUGGESTED THAT THE PATIENT MAY HAVE BEEN INCORRECTLY CONNECTED TO THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEVERAL DEVICES USED (SEE EXHIBIT A) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death