BEUDAMED
    FDA Adverse Event Summary report: N

    CASE 8000

    MDR report key: 794398 · Received November 13, 2006

    Report

    Report Number
    794398
    Date Received
    November 13, 2006
    Date of Event
    November 10, 2006
    Report Date
    November 13, 2006
    Manufacturer
    GEHC CLINICAL SERVICES
    Product Code
    BXB
    Report Source
    User Facility report
    Reporter Location
    CT, US

    Narratives

    Description of Event or Problem · 1

    A FEMALE PATIENT WAS UNDERGOING A STRESS TEST ON A GE/MARQUETTE CASE 8000 WITH ASSOCIATED TREADMILL. A DOCTOR AND A TECHNICIAN WERE MONITORING PROGRESS USING THE BRUCE PROTOCOL. PATIENT HAD COMPLETED STAGE 1 AT 1.7 MPH, 10% INCLINE, STAGE 2 AT 2.5 MPH, 12% INCLINE AND INDICATED THAT SHE WOULD LIKE TO TRY THE NEXT LEVEL AT 3.4 MPH, 14% INCLINE. PATIENT IMMEDIATELY INDICATED IT WAS TOO MUCH AND REQUESTED THAT THE MD RAMP THE SPEED AND INCLINATION DOWN. THE TECHNICIAN WAS BEHIND THE PATIENT TO PROVIDE SUPPORT IN THE EVENT THAT SHE MIGHT FALL, BUT THE MD INADVERTENTLY SELECTED THE EXERCISE KEY INSTEAD OF THE RECOVERY KEY, WHICH INCREASED THE TREADMILL SPEED AND INCLINATION EVEN FURTHER TO 4.2 MPH AT 16%. THIS WAS REPEATED AND THE DEVICE SPED TO ITS 5TH STAGE OF 5.0 MPH AT 18% INCLINATION. THE PATIENT COULD NOT KEEP PACE AND LOST HER FOOTING. SHE HELD ON WITH FEET SPRAWLED ACROSS TREADMILL AND EVENTUALLY LOST HER GRIP AND FELL. SHE RECEIVED SCRAPES AND BRUISES TO HER LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASE 8000 STRESS TEST TREADMILL BXB GEHC CLINICAL SERVICES 8000 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR NO OTHER THERAPIES