MAUDE Adverse Event Report: GE (OEM) HEALTHCARE SURGERY SURGICAL C-ARM

Model Number 9900 ELITE

Device Problems Device Alarm System (1012); Overheating of Device (1437); High Sensing Threshold (2574); Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 03/07/2019

Event Type  malfunction  

Event Description

A large c-arm was being used for a procedure.As normal, the x-ray tech announced the amount of time the c-arm was in use at the 5 min, 10 min, 15 min and 20 min.After 20 min, the c-arm showed a warning message that it was overheating.The c-arm then stopped working.The tube heat monitoring components did not operate normally, system did not announce and event messages at 80% of heat threshold reached (as if should per mfr settings).System disabled x-ray when it reached 127% of heat threshold.After clinical engineering tested system and reached out to vendor tech support, a software reload and replacement of thermal switch / temp sensor were suggested and carried out.

• Brand Name: SURGICAL C-ARM
• Type of Device: SURGICAL C-ARM
• Manufacturer (Section D): GE (OEM) HEALTHCARE SURGERY ; 384 wright brothers dr
• MDR Report Key: 8433796
• MDR Text Key: 139307264
• Report Number: 8433796
• Device Sequence Number: 1
• Product Code: JAA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 03/13/2019,03/12/2019

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: Health Professional
• Device Model Number: 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: 03/13/2019
• Distributor Facility Aware Date: 03/07/2019
• Event Location: Ambulatory Surgical Facility
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 134