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

Model Number 9800

Device Problem Loss of Data (2903)

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

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

A ge service representative performed an onsite investigation.The hard disk drive was evaluated and replaced.The system software and calibrations were also reloaded.The system was tested and found to be working as intended and returned to service.

Event Description

The customer reported that the system failed to properly save and recall patient image data.No patient serious injury or death was reported related to this event.

Manufacturer Narrative

The investigation into the reported event determined that there was no device malfunction.This is not a reportable event.Complaint investigation: the fse confirmed the problem reported by the customer of unable to pull right image, data mix.The fse determined the cause of the problem to be the hard drive.The fse replaced the hard drive to resolve the issue.As a precaution the fse instructed the customer on the waiting for the save icon to disappear before taking another image.The fse verified system functionality.The partitioned serial ata hard-drive that contains the operating systems, and also contains the system software such as patient data files.The hard drive holds software that is a set of instructions that directs the system processor to perform specific operations such as data storage.Based on age of the system, manufactured in 2003, this type of failure would be expected and reflective of the normal wear and tear that is anticipated as the system is used.

• Brand Name: 9800
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS (SLC); 384 wright brothers drive; salt lake city UT 84116
• Manufacturer (Section G): GE OEC MEDICAL SYSTEMS (SLC); 384 wright brothers drive; salt lake city UT 84116
• Manufacturer Contact: 384 wright brothers drive; salt lake city, UT 84116
• MDR Report Key: 5733914
• MDR Text Key: 47698596
• Report Number: 1720753-2016-01509
• Device Sequence Number: 1
• Product Code: OWB
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9800
• Device Lot Number: 89-1943
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2003
• 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