BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-SCRIBE COLOR STRESS TESTING SYSTEM

    MDR report key: 3407 · Received July 29, 1992

    Report

    Report Number
    3407
    Event Type
    Malfunction
    Date Received
    July 29, 1992
    Date of Event
    June 22, 1992
    Report Date
    July 2, 1992
    Manufacturer
    MORTARA INSTRUMENT, INC.
    Product Code
    IOL
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SPECIAL DIAGNOSTICS WAS IN THE PROCESS OF PERFORMING A 2DE ON THIS PATIENT. THE PATIENT HAD BEEN WALKING FOR APPROXIMATELY 5 MIN 30 SEC WHEN THE PHYSICIAN NOTIFIED THE TECH THAT HE WOULD LIKE TO TERMINATE THE EXERCISE PORTION OF THE TEST AT 6 MIN. THE TECH STARTED TO PREPARE THE MACHINE TO STOP, WHEN HE REALIZED THAT THE TRACKBALL (MOUSE) HAD FROZEN. AFTER HE DISCOVERED THAT HE COULDN'T STOP THE TREADMILL FROM THE COMPUTER DISPLAY, HE PUSHED THE EMERGENCY STOP BUTTON. AFTER PUSHING THE EMERGENCY STOP BUTTON INSTEAD OF STOPPING THE TREADMILL ADVANCED TO THE NEXT STAGE (14% ELEVATION - 3.4 MPH). AT THIS TIME AFTER TRYING THESE SERIES OF SOLUTIONS THE PATIENT WAS GETTING TIRED SO HE FELT THAT WE SHOULD GET THE PATIENT OFF OF THE TREADMILL. AT THIS TIME I STOOD BEHIND THE PATIENT ON THE TREADMILL, BOTH OF THE PATIENTS FEET WERE OFF THE TREADMILL, BUT HE WAS SUPPORTING HIMSELF WITH HIS ARMS AND THE TECH JUST STOOD BEHIND HIM AND TILTED THE PATIENT BACK OFF THE TREADMILL. THE TECH ASKED THE PATIENT IF HE WAS OK AND THE PATIENT SAID YES, BUT THE PATIENT DID APPEAR TO HAVE AN ABRASION ON HIS RIGHT KNEE. OTHER THAN THE KNEE ABRASION THERE WERE NO OTHER APPARENT AHEAD AND PERFORMED THE ECHO PORTION OF THE TEST.THE PATIENT IS A POST-OP PTCA. FOLLOWING THE INCIDENT HE EXPERIENCED LEG AND ANKLE PAIN. ANKLE X-RAY WAS NEGATIVE. HE ALSO EXPERIENCED LOW BACK PAIN. THE PATIENT WAS DISCHARGED AND WAS TO FOLLOW UP WITH AN ORTHOPEDIC SURGEON TO EVALUATE PAIN, AND IS NOW GOING TO HAVE PHYSICAL THERAPY.DEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE NOT SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-APR-92. SERVICE PROVIDED BY: MANUFACTURER. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: COMPONENT FAILURE. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 X-SCRIBE COLOR STRESS TESTING SYSTEM TREADMILL - PRODUCT TRACK MASTER IOL MORTARA INSTRUMENT, INC. 5CS8120S/5M400E/S N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other