BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASE P2 SERIES

    MDR report key: 2250776 · Received September 13, 2011

    Report

    Report Number
    2250776
    Event Type
    Malfunction
    Date Received
    September 13, 2011
    Date of Event
    August 2, 2011
    Report Date
    September 13, 2011
    Manufacturer
    GE HEALTHCARE
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN THE MIDDLE OF HAVING HIS STRESS WHEN THE TECH HAD TO PUT THE STRESS MACHINE INTO PAUSE STAGE TO KEEP IT FROM GETTING ANY FASTER. I THEN TURNED THE SPEED DOWN WHILE THE DOCTOR ENTERED THE ROOM AND TURNED THE GRADE OF THE TREADMILL DOWN AS WELL. THE DOCTOR THEN TRIED TO TURN THE SPEED DOWN AND IT WOULD NOT ALLOW HIM TO DO ANYTHING. TECH TRIED TO PUT THE PATIENT INTO RECOVERY MODE AND IT WOULD NOT DO ANYTHING. TECH STOPPED THE TREADMILL AND BROUGHT THE PATIENT BACK TO THE STRETCHER WITH NO PROBLEM. THE PATIENT WAS NOT INJURED DURING THIS TRANSITION. TECH THEN TRIED TO END THE TEST AND THE MACHINE WOULD NOT REACT TO ANYTHING. THEN TURNED THE MACHINE OFF AND RESTARTED IT. THE MACHINE WAS STILL NOT WORKING. AFTER THE PATIENT LEFT, I CALLED GE TECH SUPPORT AND WE DISCOVERED THAT THE CONTROL PANEL ON THE FRONT OF THE STRESS MACHINE WAS NOT FUNCTIONING PROPERLY. THEN PUT A WORK ORDER FOR BIOMED TO COME AND FIX IT. WE DID LOSE PEAK AND RECOVERY EKG DATA BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASE P2 SERIES CARDIAC TESTING SYSTEM DQK GE HEALTHCARE CASE P2 SERIES *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR