MAUDE Adverse Event Report: OEC MEDICAL SYSTEMS, INC. OEC; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number 9800 PLUS

Device Problems Break (1069); No Display/Image (1183); Loss of Power (1475)

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

Event Date 08/11/2017

Event Type  malfunction  

Event Description

Patient was undergoing a surgical procedure (spinal cord stimulator dorsal root ganglion trial) which requires use of a c arm.During the procedure, the c arm "popped" and "went black".The radiology tech operating the c arm shut down, and then rebooted the c arm, but the issue did not resolve.The surgeon was unable to complete the case.Machine sent to biomed for repair.

• Brand Name: OEC
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): OEC MEDICAL SYSTEMS, INC.; 384 n wright brothers dr; salt lake city UT 84116
• MDR Report Key: 6841720
• MDR Text Key: 84848079
• Report Number: 6841720
• Device Sequence Number: 1
• Product Code: OWB
• 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: 08/21/2017,08/23/2017

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: Other
• Device Model Number: 9800 PLUS
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/21/2017
• Device Age: 13 YR
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 08/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/05/2017
• 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: 52 YR