MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA IGS 520; INTERVENTIONAL FLUOROSCOPIC X-RAY SY

Model Number 171814WG7

Device Problems No Device Output (1435); Computer Operating System Problem (2898); Operating System Becomes Nonfunctional (2996)

Patient Problems Chest Pain (1776); Death (1802); Sudden Cardiac Death (2510)

Event Date 07/21/2019

Event Type  Death  

Manufacturer Narrative

Ge healthcare has initiated an investigation which is ongoing.A follow-up report will be submitted upon investigation closure.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2019, the doctor at (b)(6) hospital in (b)(6) reported that a patient arrived at the emergency department with chest pain that had begun approximately ten hours earlier.While preparing for the diagnostic cardiac catherization and possible percutaneous coronary intervention, the innova igs 520 systems computer mouse and keyboard were unresponsive.The system was rebooted several times unsuccessfully, so the doctor decided to move the patient to another facility.Two hours later, during the procedure, the patient's condition worsened and became deceased.

Manufacturer Narrative

Patient information have been provided.Operator of the device is a health professional.Ge healthcare investigation about this event has been completed.On (b)(6) 2019 customer from manipal hospital klang, located in selangor in malaysia reported to ge healthcare (gehc) field service engineer (fe) that on (b)(6) 2019, around 1:20am when a patient was on the table getting ready for the procedure, the system became unresponsive and the mouse and keyboard didn't work.After performing several reset and restart without success, the doctor decided to move the patient to another facility, sri kota specialist medical center, located also in selangor.There, the same doctor managed to do primary pci (percutaneous coronary intervention) but the patient had a cardiogenic shock and died on the table.It was concluded that the system may have contributed to the patient death.Investigation results concluded that the root cause is a system hard disk failure in the dl computer.This issue remained isolated and neither design, assembly nor manufacture defect, nor failure or malfunction has been identified.On (b)(6) 2019 gehc field service engineer replaced the dl system hard disk and loaded dl ghost & application which resolve the issue.No further action is required at that time.

• Brand Name: INNOVA IGS 520
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SY
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• MDR Report Key: 8873892
• MDR Text Key: 153678351
• Report Number: 9611343-2019-00008
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• PMA/PMN Number: K181403
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Remedial Action: Repair
• Type of Report: Initial,Followup
• Report Date: 10/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 171814WG7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Weight: 64