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

Model Number 9800

Device Problem Device Stops Intermittently (1599)

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

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

A ge service representative performed an onsite investigation.The power supply was adjusted during the service call.The system was tested and found to be working as intended and put back into service.

Event Description

The customer reported the system locked up.There was no patient injury or death reported.

• 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: 4992193
• MDR Text Key: 23093542
• Report Number: 1720753-2015-03167
• 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: company representative,health
• Reporter Occupation: Other
• Report Date: 08/06/2015

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: Health Professional
• Device Model Number: 9800
• Device Lot Number: 8S-1036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2002
• 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