MAUDE Adverse Event Report: GE HEALTHCARE INNOVA; SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED

Model Number IGS 530 002

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 08/06/2020

Event Type  malfunction  

Event Description

Broken hose to cath lab c-arm.The issue was found when opening room in the morning to start cases.Leaking fluid all over the floor.This has happened on another cath lab in this facility as well, same type of device.Probably device design flaw.Manufacturer response for cath lab - leaking hose for c-arm, ge medical systems (per site reporter).Nothing yet.

• Brand Name: INNOVA
• Type of Device: SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED
• Manufacturer (Section D): GE HEALTHCARE; 3000 n. grandview blvd; waukesha WI 53188
• MDR Report Key: 10482093
• MDR Text Key: 205288995
• Report Number: 10482093
• 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: 08/13/2020,08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IGS 530 002
• 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: 08/13/2020
• Device Age: 4 YR
• Date Report to Manufacturer: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1