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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 06/27/2015

Event Type  Death  

Manufacturer Narrative

Patient information not provided due to county privacy laws.The initial reporter is located outside the u.S.; therefore, initial reporter information is 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 did not try to reboot the system and immediately decided to transfer the patient to another hospital.The patient died during transfer to the other hospital.

Manufacturer Narrative

The hospital indicated that on (b)(6) 2015, an emergency patient (myocardial infarction) was brought to the (b)(6) hospital after a full day of uneventful device use.The patient was prepared for intervention and brought to the exam room.Meanwhile, the system shut down by itself and the staff did not attempt to restart the system.Instead the patient was immediately taken to another hospital, (b)(6) hospital, where an intervention was completed successfully despite the unanticipated extended delay in treatment.Some period after the completed intervention, the patient was being transferred back to (b)(6) hospital at which time they expired.The ge healthcare medical director confirmed that because the issue extended the delay possibly affecting the prognosis, the device failure may have been a contributing factor in the ultimate outcome.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 july 23, 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: 4975843
• MDR Text Key: 22386663
• Report Number: 9611343-2015-00008
• 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,health professional,u
• Reporter Occupation: Biomedical Engineer
• Report Date: 07/06/2015

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