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

Model Number 9900

Device Problems Device Alarm System (1012); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

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

Event Date 06/12/2014

Event Type  malfunction  

Event Description

The customer reported the system continued to beep after letting off the fluoro button.This is consistent with an intermittent system lock up.There was no uncommanded x-ray.This caused intermittent, recoverable loss of imaging functionality.There is no report of injury or death.

Manufacturer Narrative

A ge service rep performed an on site investigation.The generator ps1 power supply was evaluated and recalibrated.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 (SLC); 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: 3978958
• MDR Text Key: 4815803
• Report Number: 1720753-2014-05508
• 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: 06/26/2014

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: 9900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2014
• Initial Date FDA Received: 06/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2008
• 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