MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 3131-IQ; INTERVENTIONAL FLUOROSCOPIC X-RAY SY

Device Problems Circuit Failure (1089); Loss of Power (1475); Device Stops Intermittently (1599); Computer Operating System Problem (2898)

Patient Problems Stroke/CVA (1770); No Known Impact Or Consequence To Patient (2692)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.Ge healthcare 's investigation into reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

It was reported that during a stroke intervention case, x-ray imaging was lost.The system was shutdown and rebooted.The case was completed after the system reboot.

Manufacturer Narrative

Patient information was not provided by customer.There was no injury reported.Type of reportable event was corrected to malfunction.Investigation of this event was performed using information provided by ge healthcare field service engineer on site and analysis of logs from the system.During an emergency procedure for a patient stroke, the system lost its x-ray capability twice during critical phase of the procedure.Each time, the system was recovered by a reset and it caused a delay of 10 minutes.Customer reported no measurable neurological harm in delivering a clot-busting thrombolytic drug with no extended patient stay.The procedure was completed without further sequelae.As of today, there was no injury reported by the hospital.It has been confirmed that there was no injury associated with this event.The log analysis showed that the dl (digital leader) computer has reset twice abruptly during the procedure causing system lock-up.The most probable root cause of this issue has been identified as a temporary failure of the pci (peripheral component interconnect) controller in dl computer during the procedure.Neither defect nor pattern has been identified with this component.This system was corrected by replacing dl computer on november 7, 2016.Based on this analysis, neither corrective nor preventive action has been deemed necessary, and no further action is required at that time.

• Brand Name: INNOVA 3131-IQ
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc ; FR
• Manufacturer Contact: elodie fins ; 283 rue de la miniere; buc ; FR
• MDR Report Key: 6127476
• MDR Text Key: 60875828
• Report Number: 9611343-2016-00016
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/27/2016
• 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): Other