MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS GMBH 7900; FLUOROSCOPIC X-RAY

Model Number 7900

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

The fse reported that the system had no power.This resulted in a total loss of imaging functionality.There is no report of injury or death associated with this event.

Manufacturer Narrative

A ge service rep performed an on site investigation.The interconnect cable was replaced during the service call.The system was tested and found to be working as intended and put back into service.

• Brand Name: 7900
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS GMBH; 14 wilhelm-maisel-str.; wendelstein ; GM
• Manufacturer (Section G): GE OEC MEDICAL SYSTEMS GMBH; 14 wilhelm-maisel-str.; wendelstein D-90 530; GM D-90530
• Manufacturer Contact: 384 wright brothers dr.; salt lake city, UT 84116 ; 8015364952
• MDR Report Key: 3804365
• MDR Text Key: 4364620
• Report Number: 9680959-2014-00308
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2014
• 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