MAUDE Adverse Event Report: GE MEDICAL SYSTEMS SCS INNOVA 2100-IQ; ANGIOGRAPHIC X-RAY SYSTEM

Device Problems Loss of Power (1475); Computer Operating System Problem (2898)

Patient Problem Death (1802)

Event Date 06/23/2015

Event Type  Death  

Manufacturer Narrative

Patient information not provided due to country privacy laws.

Event Description

It was reported that an emergency case arrived at the hospital with a myocardial infarction.The patient was prepared for intervention and brought to the exam room but the system shut down by itself.The user attempted to reboot the system twice without success.Following the unsuccessful reboot attempts, the medical staff decided to transfer the patient to another hospital.The patient died during transfer to other hospital.

Manufacturer Narrative

It has been determined during troubleshooting that this issue was due to an intermittent failure of the r5 relay within ce power distribution box (pdb) of the vascular system which caused the intermittent system shut down.This relay is used to control voltage and phase of the facility power supply.Autopsy did not reveal any specific malfunction of the r5 relay.No pattern has been identified with r5 relay.The site has been corrected on (b)(6) 2015 by replacing the r5 relay.After replacement of the component, the ce pdb and system were up and running.No further action is required.

• Brand Name: INNOVA 2100-IQ
• Type of Device: ANGIOGRAPHIC X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; buc ; FR
• Manufacturer (Section G): GE MEDICAL SYSTEMS SCS; 283 rue de la miniere; buc 78530 ; FR 78530
• Manufacturer Contact: james giles ; 3000 n grandview blvd, w450; w450; waukesha, WI 53188 ; 2625482089
• MDR Report Key: 4975871
• MDR Text Key: 22387041
• Report Number: 9611343-2015-00010
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• PMA/PMN Number: K092004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Biomedical Engineer
• Report Date: 06/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death