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

Model Number 7900

Device Problems Degraded (1153); No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2014

Event Type  malfunction  

Event Description

The customer reported the fluoroscopic image was degraded effectively eliminating the ability to view a usable image.No pt serious injury or death was reported related to this event.

Manufacturer Narrative

No conclusion can be drawn as conclusive repair info is unavailable at this time and no add'l service info was provided.

• Brand Name: 7900
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS GMBH; 14 wilhelm-maisel-str.; wendelstein D-90 530; GM D-90530
• 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: 3860921
• MDR Text Key: 4455337
• Report Number: 9680959-2014-00516
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2014

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: 7900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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