MAUDE Adverse Event Report: GE MEDICAL SYSTEMS LLC INNOVA; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE

Model Number IGS 530

Device Problems Crack (1135); Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 11/22/2018

Event Type  malfunction  

Event Description

During a case in cath lab room number two the coolant hose ruptured.The case finished.The x-ray machine was opened by biomed to reveal a ruptured hose.Manufacturer response for radiology device for shooting films during cardiac cath procedures, gems innova (per site reporter).Disassembled flexible elbow assembly into c-arm orbital movement and discovered tube chilling water hose ruptured/cracked; filling entire x-ray tube containment and housing all the way back to elbow.

• Brand Name: INNOVA
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE
• Manufacturer (Section D): GE MEDICAL SYSTEMS LLC; 3000 n grandview blvd.; waukesha WI 53188
• MDR Report Key: 8178304
• MDR Text Key: 130794989
• Report Number: 8178304
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/06/2018,12/04/2018

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: IGS 530
• 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: 12/06/2018
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1