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

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 02/13/2018

Event Type  malfunction  

Event Description

C-arm was brought into operating room prior to start of procedure and turned on.Upon turning on the c-arm, the screen said "voltage error, restart system".C-arm was restarted 4 times and bio-med was called.Bio-med came to the operating room and again tried to restart the machine and bypass the error code.Bio-med was not able to fix the malfunction and proceeded to call the help number on the back of the machine.Initially, another c-arm was not available.Once another c-arm became available, the c-arm that was not working was removed from the room and a new c-arm was brought into the room to start the procedure.

• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS, INC; 384 n wright brothers dr; salt lake city UT 84116
• MDR Report Key: 7925798
• MDR Text Key: 122352815
• Report Number: 7925798
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2018

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32850 DA
• Patient Weight: 170