MAUDE Adverse Event Report: GE HEALTHCARE INNOVA 2100; SYSTEM, X-RAY, ANGIOGRAPHIC

Model Number 5314431-10

Device Problems Loss of Power (1475); Failure to Power Up (1476); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/20/2016

Event Type  malfunction  

Event Description

Ge innova fluoroscopy machine completely shut down twice during the procedure.Attempted multiple times to reboot the machine but efforts were unsuccessful.Patient was not harmed.Machine malfunction delayed coronary angiogram procedure.

• Brand Name: INNOVA 2100
• Type of Device: SYSTEM, X-RAY, ANGIOGRAPHIC
• Manufacturer (Section D): GE HEALTHCARE; 9900 w. innovation dr.; rp-2138; wawatosa WI 53226
• MDR Report Key: 6188627
• MDR Text Key: 62858924
• Report Number: 6188627
• Device Sequence Number: 1
• Product Code: IZI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 5314431-10
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/20/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR