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

Model Number 9900

Device Problem Loss of Data (2903)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/25/2015

Event Type  malfunction  

Event Description

The customer reported the system would not recall images and had a loss of data.There was no pt injury or death reported.

Manufacturer Narrative

A ge service rep performed an onsite investigation.The hard drive and the software were installed during the service call.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; 384 wright brothers dr.; salt lake city UT 84116
• Manufacturer Contact: 384 wright brothers dr.; salt lake city, UT 84116 ; 8015364952
• MDR Report Key: 4927973
• MDR Text Key: 6032341
• Report Number: 1720753-2015-02888
• 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: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9900
• Device Lot Number: 89-2632
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/25/2015
• 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