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

Model Number 107250

Device Problems Mechanical Problem (1384); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

Patient was taken back to operation room for procedure in the morning and it was discovered the c-arm was not functioning correctly.Procedure could not be completed without the c-arm, so it was canceled.Patient was discharged home.The entire scheduled day had to be canceled due to the c-arm not working.In total 14 cases were canceled.Manufacturer notified, tech coming out to look at carm.

• Brand Name: IMAGING
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS, INC.; 384 n wright brothers dr; salt lake city UT 84116
• MDR Report Key: 16146029
• MDR Text Key: 307186734
• Report Number: 16146029
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2022

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: 107250
• 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: 12/27/2022
• Date Report to Manufacturer: 01/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1