MAUDE Adverse Event Report: UNKNOWN GE; C-ARM X-RAY

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 07/10/2015

Event Type  malfunction  

Event Description

The catheter laboratory room had a "gantry failure, call service" error message regarding the c-arm x-ray.The procedure was moved to a second cardiac catheter laboratory room resulting in a 45 minute procedure delay but no other patient impact.The biomed was able to resolve the malfunction.

• Brand Name: GE
• Type of Device: C-ARM X-RAY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5084572
• MDR Text Key: 26071431
• Report Number: 5084572
• Device Sequence Number: 1
• Product Code: JAA
• 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
• Report Date: 07/28/2015,09/01/2015

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: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR