BEUDAMED
    FDA Adverse Event Death Summary report: N

    9900

    MDR report key: 7760266 · Received August 7, 2018

    Report

    Report Number
    1720753-2018-00002
    Event Type
    Death
    Date Received
    August 7, 2018
    Date of Event
    July 15, 2018
    Report Date
    November 6, 2018
    Manufacturer
    GE OEC MEDICAL SYSTEMS, INC
    Product Code
    OWB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED OCCURRENCE IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION HAS BEEN COMPLETED. PATIENT INFORMATION COULD NOT BE OBTAINED AFTER MULTIPLE ATTEMPTS. (B)(4).

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION INTO THE REPORTED EVENT IS COMPLETE. THE LOG FILE ANALYSIS AND SYSTEM CYCLING DATA INDICATE THAT BAD THERMISTOR READINGS RESULTED IN THE PREMATURE DISPLAY OF A HOUSING HOT MESSAGE ON 6/24 AND THE ANOMALOUS HOUSING OVERHEATED MESSAGE ON 7/15. THE THERMISTOR (ALSO REFERRED TO AS THE TEMPERATURE SENSOR IN THE SERVICE PROCEDURES) IS LISTED IN THE ILLUSTRATED PARTS MANUAL AS A FRU. WHEN THE THERMISTOR READING ERROR WAS IDENTIFIED ON 6/24, THE THERMISTOR SHOULD HAVE BEEN REPLACED AND NOT CLEANED. THE THERMISTOR CLEANING WAS AN INCORRECT SERVICE ACTION AS THERE ARE NO CLEANING INSTRUCTIONS FOR THE THERMISTOR AND THE CLEANING OF THE THERMISTOR CANNOT ENSURE RESOLUTION OF ANOMALOUS THERMISTOR READINGS. THE THERMISTOR WAS REPLACED DURING THE COURSE OF THE INVESTIGATION. THE PATIENT IN THIS CASE WAS REPORTED AS PRESENTING IN CRITICAL CONDITION WITH CHEST PAIN AND MYOCARDIAL INFARCTION. NO FURTHER DETAILS ARE KNOWN AS THE CUSTOMER IS NOT WILLING TO PROVIDE ADDITIONAL INFORMATION SURROUNDING THIS EVENT DESPITE MULTIPLE ATTEMPTS TO GATHER THIS INFORMATION. THEREFORE, GIVEN THE LIMITED INFORMATION AVAILABLE IT CANNOT BE DETERMINED IF THE DEVICE CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) THE SYSTEM DISPLAYED A HOUSING OVERHEATED MESSAGE AND X-RAY WAS DISABLED. THE PROCEDURE COULD NOT BE COMPLETED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598073 9900 FLUOROSCOPIC X-RAY OWB GE OEC MEDICAL SYSTEMS, INC ESCMHX07449

    Patients

    Seq Age Sex Outcome Treatment
    1 Death