BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPACE LABS MONITOR

    MDR report key: 34715 · Received June 27, 1996

    Report

    Report Number
    34715
    Event Type
    Injury
    Date Received
    June 27, 1996
    Date of Event
    March 3, 1996
    Manufacturer
    SPACE LABS MEDICAL, INC.
    Product Code
    DRT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 3/3/96, CO'S MONITOR WAS ON A PT IN THE SURGICAL INTENSIVE CARE UNIT. THE PT, A 74-YR-OLD FEMALE, DEVELOPED VENTRICULAR FIBRILLATION FOR WHICH SHE WAS DEFIBRILLATED. IMMEDIATELY AFTER THE DISCHARGE OF THE DEFIBRILLATOR, THE MONITOR WENT BLANK LEAVING THE HEALTH CARE TEAM WITHOUT VITAL EKG TRACINGS. RPTR HAS BEEN TOLD THE MONITOR WAS BLANK/NOT FUNCTIONAL FOR A PERIOD OF 1-1/2 TO 4 MINS WHILE THE PT WAS IN A "CODE" SITUATION. THE PT WAS DEFIBRILLATED A SECOND TIME (THE PT STILL HAD NO PULSE) AND JUST BEFORE DEFIBRILLATING AGAIN, THE MONITOR CAME BACK UP INDICATING THAT THE PT HAD AN ACCEPTABLE RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPACE LABS MONITOR MONITOR DRT SPACE LABS MEDICAL, INC. 90305-04-10/305004499

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention