MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS 9900; FLUOROSCOPIC X-RAY

Model Number 9900

Device Problems Difficult or Delayed Activation (2577); Loss of Data (2903)

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

Event Date 03/13/2015

Event Type  malfunction  

Event Description

The customer reported that the system failed to power to a usable state and exhibited a non-recoverable loss of functionality.No patient serious injury or death was reported related to this event.

Manufacturer Narrative

A ge service representative performed an onsite investigation.The fse evaluated and replaced the intelligent shutdown pcb and surge suppressor pcb.The fse also found the connector was not seated fully on cable which carries ac power line sensing signal between surge suppressor and systems interface pcbs.The connector was reseated during the service event.The system was tested and found to be working as intended and returned to service.

• Brand Name: 9900
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS; 384 wright brothers dr.; salt lake city UT 84116
• Manufacturer (Section G): 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: 4680399
• MDR Text Key: 17575697
• Report Number: 1720753-2015-01476
• 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: 04/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2006
• 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