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

Model Number XCA108

Device Problems No Display/Image (1183); Appropriate Term/Code Not Available (3191)

Patient Problem Cardiac Arrest (1762)

Event Date 02/09/2016

Event Type  Injury  

Manufacturer Narrative

Patient weight is currently unavailable.; incident date is currently unavailable.Healthcare's investigation into the reported occurrence is still ongoing.A follow-up report will be issued when the investigation has been completed.

Event Description

It was reported that during a trans-catheter aortic valve replacement procedure, while deploying the valve, the system lost imaging and had to be rebooted.The patient had a cardiac arrest during the reboot of the system and underwent cpr and recovered well.

Manufacturer Narrative

On(b)(6) 2016, (b)(6) reported to a ge healthcare (gehc) field engineer (fe) that the gehc system shut down in the middle of a transcatheter aortic valve replacement (tavr) while deploying valve.Customer rebooted successfully.During reboot, patient experienced a cardiac arrest but recovered well.Procedure was completed successfully.Investigation of this event used information from gehc fe and system logs.The system is not under gehc service contract.The system does not have a fluoro uninterruptible power supply (ups) but has a system ups of 190 kva maintained by the customer to back up system in case of main power failure.Gehc engineering log analysis confirmed abrupt shutdown of the system as if emergency power off (epo) was activated.The contract company providing system maintenance confirmed that the pdb (power distribution box) had to be turned on after the abrupt shutdown before the system could be turned on from the console.The system booted in 4 min after turning on the pdb button in control room.Gehc fe verified all the pdb main connections and the power distribution unit (pdu) ups to be normal.Gehc fe also verified the continuity and impedance of the epo and no issue was observed.Site history shows this is the first time abrupt shutdown was reported after installation in 2006.Based on the available information, the probable root cause is accidental epo activation.The customer is aware of the potential for accidental remote epo activation.Based on this analysis, no further action is required.

• Brand Name: INNOVA 2100
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): GE MEDICAL SYSTEMS SCS; ra 283 rue de la miniere; buc, france 78530 ; FR 78530
• Manufacturer Contact: joseph seliga ; 3000 n grandview blvd.; wauklesha, WI 53188 ; 2625443620
• MDR Report Key: 5496188
• MDR Text Key: 40201493
• Report Number: 9611343-2016-00002
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

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
• Device Model Number: XCA108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 87 YR