MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 9800; FLUOROSCOPIC X-RAY

Model Number 9800

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

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

Event Date 05/19/2015

Event Type  malfunction  

Event Description

The customer reported that the system locked up.No pt serious injury or death was reported related to this event.

Manufacturer Narrative

A ge service rep performed an on site investigation and determined a cpu upgrade was required.The fse removed and replaced the single board computer kit, video controller pcb, system interface pcb, image processor pcb, display adaptor pcb, workstation backplane, hard disk drive, cine disk drive, generator interface board and fluoroscopy functions pcb.The system was tested and found to be working as intended and put back into service.

• Brand Name: 9800
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS (SLC); 384 wright brothers dr.; salt lake city UT 84116
• Manufacturer Contact: 384 wright brothers dr.; salt lake city, UT 84116 ; 8015364952
• MDR Report Key: 4840711
• MDR Text Key: 21468293
• Report Number: 1720753-2015-02380
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

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: Lay User/Patient
• Device Model Number: 9800
• Device Lot Number: 89-0401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2015
• Initial Date FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2000
• 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