MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 3100-IQ; INTERVENTIONAL FLUOROSCOPIC X-RAY

Model Number XCA323

Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198); Difficult To Position (1467); Device Displays Incorrect Message (2591); Computer Operating System Problem (2898); Device Operates Differently Than Expected (2913)

Patient Problems Calcium Deposits/Calcification (1758); Death (1802); Myocardial Infarction (1969)

Event Date 07/30/2016

Event Type  Death  

Manufacturer Narrative

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.

Event Description

It was reported that a patient transported from the emergency department with symptoms consistent with myocardial infarction in stable/guarded condition, was undergoing a coronary angiography examination when the system lost gantry motion.The system was rebooted and recovered after about 10 minutes.The system regained all functionality and intervention procedures were attempted for several hours.Due to severe coronary calcifications, a stent could not be placed.Despite life saving measures, the patient expired.

Manufacturer Narrative

On (b)(6) 2016, patient was presented from the emergency department with symptoms consistent with myocardial infarction in stable/guarded condition.Patient was not tolerating exam well and complained of pain.Diagnostic portion of the exam was complete.Triple vessel disease was present.The exam continued for about 10 min and gantry movement froze with error message on the monitor.The system regained all functionality within 6 min after a system off/on and intervention was continued for 2 hours.Due to severe coronary calcifications, a stent could not be placed.The patient was coded in the room, consistent with acls standards, intubated, intra-aortic balloon pump placed.Despite life saving measures, patient expired.Although there was no x-ray inhibit and table movement was available, due to non-availability of the gantry axis, system contributed to about 6 minutes delay in the procedure but it cannot be determined if it contributed to the patient death.The investigation concluded that this error was due to the smart box which generated an ?enable? signal and prevented gantry motions.However, autopsy of the part was conducted but the issue could neither be reproduced nor any signs of wearing, aging or other faults that could explain the random enable signal which prevented motions.The analysis of the system design concluded that the root cause for the random error seen may be due to a temporary issue with the l-arm enable sense circuit of the smart box.No defect was found with the design of the system.Smart box was proactively replaced.Neither corrective nor preventive action has been deemed necessary.

• Brand Name: INNOVA 3100-IQ
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• Manufacturer (Section G): GE MEDICAL SYSTEMS S.C.S; rue de la miniere; 283; buc 78530 ; FR 78530
• Manufacturer Contact: sabrina aadjou ; 283 rue de la miniere; buc 78530 ; FR 78530
• MDR Report Key: 5850651
• MDR Text Key: 51268096
• Report Number: 9611343-2016-00014
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 08/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: XCA323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 55 YR