MAUDE Adverse Event Report: GE HEALTHCARE GE ; FLUOROSCOPIC INTERVENTIONAL X-RAY SYSTEM

Model Number CARDIO INNOVA 3100 HARMONY

Device Problems Loss of Power (1475); Computer Operating System Problem (2898); Inappropriate or Unexpected Reset (2959)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2020

Event Type  malfunction  

Event Description

During intervention of right coronary bypass graft/stent placement, ge innova t-ray equipment had a "cooling failure / secure patient / shutting off in 3 min" warning, machine shut down, 1 gallon of coolant added to chiller, rebooted machine with no warnings noted.Continued with procedure.Pt remained stable through out the 10 min reboot with no untoward effects noted.X-ray machine shut down at a critical time.A stent had been deployed and the cardiologist was unable to visualize the artery for any possible complications.

• Brand Name: GE
• Type of Device: FLUOROSCOPIC INTERVENTIONAL X-RAY SYSTEM
• Manufacturer (Section D): GE HEALTHCARE
• MDR Report Key: 9646805
• MDR Text Key: 177356548
• Report Number: MW5092625
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIO INNOVA 3100 HARMONY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 115