MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 8800; FLUOROSCOPIC X-RAY

Model Number 8800

Device Problem Loss of Power (1475)

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

Event Date 04/08/2015

Event Type  malfunction  

Event Description

The customer reported that the system experienced an un-commanded shut down.There is no report of a pt injury or death associated with this event.

Manufacturer Narrative

A ge service representative performed an onsite investigation.The monobolock controller, ps1 power supply and cpu battery were evaluated and replaced.The system software and calibrations were also evaluated and reloaded.The system was tested and found to be working as intended and returned to service.

• Brand Name: 8800
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS (SLC); 384 wright brothers dr.; salt lake city UT 84116
• Manufacturer (Section G): 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: 4726869
• MDR Text Key: 5744638
• Report Number: 1720753-2015-01775
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/22/2015

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: 8800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2015
• Initial Date FDA Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2005
• 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