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

Model Number SERIES 9800

Device Problems Use of Incorrect Control/Treatment Settings (1126); Malposition of Device (2616); Inappropriate or Unexpected Reset (2959)

Patient Problem Insufficient Information (4580)

Event Date 01/31/2007

Event Type  Other  

Event Description

Patient in for endovascular aaa stent repair.During middle of case, c-arm went into "overload" alarm.Machine was rebooted and case proceeded.Prior to shutdown, the doctor had partially placed a stent into the aorta in a "magnification mode." when c-arm rebooted, it came back up in "normal" mode.The doctor finished the stent placement in "normal" mode not realizing c-arm was not in "magnification mode." an extra stent has to be opened to repair malposition secondary to c-arm malfunction.

• Brand Name: GE OEC 9800
• 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: 16784091
• MDR Text Key: 313718309
• Report Number: 16784091
• 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: 04/19/2023,02/07/2007

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: SERIES 9800
• Device Lot Number: RE0975
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2023
• Date Report to Manufacturer: 04/21/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Male