MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 2600; FLUOROSCOPIC X-RAY

Model Number 2600

Device Problem Fire (1245)

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

Event Date 01/07/2015

Event Type  malfunction  

Event Description

During fe repairs a system board ignited.This was a contained fire without injury to the facility staff and fe.There was no allegation of an injury or death associated with the malfunction.

Manufacturer Narrative

A ge service representative performed an on site investigation.The system is in an unknown state since flame retardant was needed and could have affected the electronics and require an unknown number of extra parts to bring system back on-line.The customer given go ahead to resume repair work and ordered parts.The reported issue is currently under investigation.

Manufacturer Narrative

A root cause investigation was completed.The investigation determined that there are no product or design issues that contributed to the fire.The most likely cause was determined to be an electrical short circuit between the room-in-use signal and the adjacent +12 vdc line that was caused accidentally during the troubleshooting process.

• Brand Name: 2600
• 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: 4487691
• MDR Text Key: 20327375
• Report Number: 1720753-2015-00505
• 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,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/03/2015

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: 2600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 02/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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