MAUDE Adverse Event Report: GE HANGWEI MEDICAL SYSTEMS CO., LTD. BRIVO 785; FLUOROSCOPIC X-RAY

Model Number BRIVO 785

Device Problem Defective Device (2588)

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

Event Date 02/05/2014

Event Type  malfunction  

Event Description

It was reported that the system failed to perform fluoroscopy due to defective footswitch and hand switch.No patient serious injury or death was reported related to this event.

Manufacturer Narrative

A ge service representative performed an onsite investigation.The j14 connector on the mother board had a defective pin.The pin was reseated.The system was tested and found to be working as intended and returned to service.

• Brand Name: BRIVO 785
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; no.1, yong chang north rd.; beijing econ.&tech.dev.zone; beijing pr 1001 176; CH 1001176
• Manufacturer (Section G): GE HANGWEI MEDICAL SYSTEMS CO., LTD.; no.1, yong chang north rd.; beijing econ.&tech.dev.zone; beijing pr 1001 76; CH 100176
• Manufacturer Contact: 384 wright brothers dr.; salt lake city, UT 84116 ; 8015364952
• MDR Report Key: 3755568
• MDR Text Key: 4483351
• Report Number: 9613445-2014-00005
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/12/2014

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: BRIVO 785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2014
• Initial Date FDA Received: 02/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1