MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS, INC OEC 9800; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number 00-888169-01

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 06/09/2016

Event Type  malfunction  

Event Description

During ercp, c-arm equipment failed to expose when using hlf button on the foot switch and the hand held switch for 3 beeps.An error message appears on the screen telling the tech to power off and wait 10 seconds.A clinical engineering group was notified to conduct service maintenance and test the c-arm.

• Brand Name: OEC 9800
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS, INC; 384 wright brothers drive; salt lake city UT 84116
• MDR Report Key: 5815032
• MDR Text Key: 50184636
• Report Number: 5815032
• 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
• Type of Report: Initial
• Report Date: 06/24/2016,06/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 00-888169-01
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2016
• Device Age: 12 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/24/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2016
• 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: 41 YR