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

Model Number 9900

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 06/09/2015

Event Type  malfunction  

Event Description

The customer reported that workstation transport handle became detached from the system due to a broken screw.No pt injury was reported.

Manufacturer Narrative

A ge service rep performed an onsite investigation.The workstation handle was evaluated and replaced.The system was tested and found to be working as intended and returned to service.

• Brand Name: 9900
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): 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: 4898219
• MDR Text Key: 17588601
• Report Number: 1720753-2015-02641
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2015

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
• Device Lot Number: E2-7331-MH
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/09/2015
• Initial Date FDA Received: 07/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2011
• 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