BEUDAMED
    FDA Adverse Event Death Summary report: N

    INNOVA 3100-IQ

    MDR report key: 4949536 · Received July 29, 2015

    Report

    Report Number
    9611343-2015-00007
    Event Type
    Death
    Date Received
    July 29, 2015
    Date of Event
    February 27, 2013
    Report Date
    June 29, 2015
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    OWB
    PMA / PMN Number
    K092004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION HAS BEEN COMPLETED. THIS SITE IS SERVICED BY AN AN IN-HOUSE THIRD PARTY SERVICE TECHNICIAN WHO FOUND THAT THE TECHNICAL ROOM WAS EXTREMELY WARM DUE TO THE HOSPITAL AIR CONDITIONER WALL MOUNT THERMOSTAT FAILURE AND INFORMED HOSPITAL STAFF THAT AIR CONDITIONING HAD TO BE REPAIRED. IT WAS CONFIRMED THAT THE HOSPITAL AIR-CONDITIONING FAILURE CAUSED A SUDDEN INCREASE OF TEMPERATURE IN THE TECHNICAL ROOM RESULTING IN A CHILLER THERMAL PROTECTION RELAY ACTIVATION WHICH INHIBITS ALL X-RAY IMAGING FUNCTIONALITY AFTER A 3 MIN WARNING BECAUSE THE X-RAY TUBE CANNOT BE COOLED ANYMORE. THIS IS THE NORMAL BEHAVIOR OF THE VASCULAR SYSTEM. THE OPERATOR MANUAL CLEARLY HIGHLIGHTS SYSTEM ENVIRONMENTAL SPECIFICATIONS (INCLUDING TEMPERATURE/HUMIDITY). THE USER SHOULD INSTALL AND MAINTAIN AIR CONDITIONING TO AVOID TEMPERATURE RISES BEYOND THE SPECIFICATIONS. IN THE EVENT OF HIGH ROOM TEMPERATURE RESULTING IN THE CHILLER RELAY ACTIVATION, THE INNOVA SYSTEM DISPLAYS AN ALARM ON THE IN-ROOM MONITOR ALERTING THE USER THAT X-RAY FUNCTIONALITY WILL BE DISABLED IN 3 MIN, GIVING SUFFICIENT TIME TO SECURE THE PATIENT. THE SYSTEM WAS CORRECTED ON (B)(6) 2013 BY IN-HOUSE THIRD PARTY SERVICE TECHNICIAN BY COOLING THE TECHNICAL ROOM AND RESETTING THE CHILLER HIGH PRESSURE CUT OUT RELAY. THE CUSTOMER WAS ALSO INFORMED TO REPAIR THE AIR CONDITIONING, AND HAS BEEN INFORMED SEVERAL TIMES IN THE PAST TO CORRECTLY MAINTAIN THE TECHNICAL ROOM TO ENSURE PROPER SYSTEM FUNCTIONING. NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED, THE SYSTEM WORKED AS INTENDED AND PER SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT CURRENTLY NOT AVAILABLE. INITIAL REPORTER EMAIL NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION HAS BEEN COMPLETED. THIS SITE IS SERVICED BY AN IN-HOUSE THIRD PARTY SERVICE TECHNICIAN WHO FOUND THAT THE TECHNICAL ROOM WAS EXTREMELY WARM DUE TO THE HOSPITAL AIR CONDITIONER WALL MOUNT THERMOSTAT FAILURE AND INFORMED HOSPITAL STAFF THAT AIR CONDITIONING HAD TO BE REPAIRED. IT WAS CONFIRMED THAT THE HOSPITAL AIR-CONDITIONING FAILURE CAUSED A SUDDEN INCREASE OF TEMPERATURE IN THE TECHNICAL ROOM RESULTING IN A CHILLER THERMAL PROTECTION RELAY ACTIVATION WHICH INHIBITS ALL X-RAY IMAGING FUNCTIONALITY AFTER A 3 MIN WARNING BECAUSE THE X-RAY TUBE CANNOT BE COOLED ANYMORE. THIS IS THE NORMAL BEHAVIOR OF THE VASCULAR SYSTEM. THE OPERATOR MANUAL CLEARLY HIGHLIGHTS SYSTEM ENVIRONMENTAL SPECIFICATIONS (INCLUDING TEMPERATURE/HUMIDITY). THE USER SHOULD INSTALL AND MAINTAIN AIR CONDITIONING TO AVOID TEMPERATURE RISES BEYOND THE SPECIFICATIONS. IN THE EVENT OF HIGH ROOM TEMPERATURE RESULTING IN THE CHILLER RELAY ACTIVATION, THE INNOVA SYSTEM DISPLAYS AN ALARM ON THE IN-ROOM MONITOR ALERTING THE USER THAT X-RAY FUNCTIONALITY WILL BE DISABLED IN 3 MIN, GIVING SUFFICIENT TIME TO SECURE THE PATIENT. THE SYSTEM WAS CORRECTED ON FEBRUARY 27, 2013 BY IN-HOUSE THIRD PARTY SERVICE TECHNICIAN BY COOLING THE TECHNICAL ROOM AND RESETTING THE CHILLER HIGH PRESSURE CUT OUT RELAY. THE CUSTOMER WAS ALSO INFORMED TO REPAIR THE AIR CONDITIONING, AND HAS BEEN INFORMED SEVERAL TIMES IN THE PAST TO CORRECTLY MAINTAIN THE TECHNICAL ROOM TO ENSURE PROPER SYSTEM FUNCTIONING. NO SYSTEM MALFUNCTION HAS BEEN IDENTIFIED, THE SYSTEM WORKED AS INTENDED AND PER SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    ON JUNE 29, 2015, GE HEALTHCARE RECEIVED A NOTIFICATION THAT A PATIENT DEATH OCCURRED ON (B)(6) 2013. THE PATIENT WAS UNDERGOING A CORONARY ANGIOGRAPHY EXAMINATION AND THE SYSTEM SHUT DOWN DURING THE EXAMINATION DUE TO A HIGH AMBIENT TEMPERATURE IN THE TECHNICAL ROOM. THE CUSTOMER DID NOT INFORM GE HEALTHCARE OF THIS EVENT WHEN IT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493206 INNOVA 3100-IQ INTERVENTIONAL FLUOROSCOPIC X-RAY OWB GE MEDICAL SYSTEMS SCS 602239LAB4

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death