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

Model Number 7900

Device Problems Connection Problem (2900); Material Integrity Problem (2978)

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

Event Date 09/19/2013

Event Type  malfunction  

Event Description

The customer reported that they were unable to connect workstation to the c-arm due to a defective cable.This resulted in loss of system functionality.There is no report of injury or death associated with the event.

Manufacturer Narrative

A ge service rep performed an onsite investigation.The cable had defective locator pins.The pins were evaluated and replaced.The system was tested and found to be working as intended and returned to service.

• 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: 3838353
• MDR Text Key: 4615066
• Report Number: 9680959-2014-00325
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/11/2014

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: 02/26/2014
• Initial Date FDA Received: 03/11/2014
• 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