MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS, INC OEC 9900 ELITE; INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM

Model Number OEC 9900 ELITE

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 03/23/2022

Event Type  malfunction  

Event Description

Patient admitted for placement of 8 french open-ended powerport into the right subclavian vein.C-arm of fluoroscopy machine malfunctioned.Team attempted using a mini fluoroscopy machine used by our orthopedic surgeons but the gap was too short to place along the anterior chest.Next, a x-ray plate was placed along patient's back and a portable chest x-ray was obtained which confirmed the guidewire going towards the right atrium.Surgeon notes throughout the procedure, a portable chest x-ray was obtained under sterile conditions for placement of this 8 french open-ended powerport.Surgeon interpreted the chest x-ray findings.

• Brand Name: OEC 9900 ELITE
• Type of Device: INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS, INC; 384 n. wright brothers dr.; salt lake city UT 84116
• MDR Report Key: 13964447
• MDR Text Key: 288291954
• Report Number: 13964447
• Device Sequence Number: 1
• Product Code: OWB
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OEC 9900 ELITE
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2022
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Male