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

Model Number 9900

Device Problem Battery Problem (2885)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

The customer reported that the system had an overload fault and would not boot up.There was no pt injury or death reported.

Manufacturer Narrative

A ge service rep performed an onsite investigation.The filament was calibrated during the service call.The system was tested and found to be working as intended and put back into 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 Contact: 384 wright brothers dr.; salt lake city, UT 84116 ; 8015364952
• MDR Report Key: 4751427
• MDR Text Key: 5825187
• Report Number: 1720753-2015-01909
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2015

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/01/2015
• 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