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

Model Number 9900

Device Problem Device Stops Intermittently (1599)

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

Event Date 06/30/2015

Event Type  malfunction  

Event Description

The customer reported that the system locked up.No patient serious injury or death was reported related to this event.

Manufacturer Narrative

The customer cancelled the service call.The lemo portion of the interconnect cable was evaluated by the customer and a pin was repaired.The system was tested and found to be working as intended and returned to service.The customer cancelled the service call.The lemo portion of the interconnect cable was evaluated by the customer and a pin was repaired.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 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: 4950624
• MDR Text Key: 6191518
• Report Number: 1720753-2015-03060
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/29/2015

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: 9900
• Device Lot Number: E2-3440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 07/29/2015
• Date Device Manufactured: 05/03/2013
• 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