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

Model Number 9900

Device Problem Detachment Of Device Component (1104)

Patient Problem No Patient Involvement (2645)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

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

Manufacturer Narrative

The investigation into the reported event determined that there was no device malfunction.This is not a reportable event.Complaint investigation: the fse confirmed the problem reported by the customer of a workstation handle broke off.Fse determined the cause of the problem to be the handle bolts broke.There was no sign of misuse.Fse replaced the broken handle to resolve the issue.Based on the age of this system (manufactured in may 2009), this type of failure would be expected and reflective of the normal wear and tear that is anticipated as the system is used, and therefore is not a malfunction.

• Brand Name: 9900
• Type of Device: FLUOROSCOPIC X-RAY
• Manufacturer (Section D): GE OEC MEDICAL SYSTEMS (SLC); 384 wright brothers drive; salt lake city UT 84116
• Manufacturer (Section G): GE OEC MEDICAL SYSTEMS (SLC); 384 wright brothers drive; salt lake city UT 84116
• Manufacturer Contact: 384 wright brothers drive; salt lake city, UT 84116
• MDR Report Key: 5848520
• MDR Text Key: 51230261
• Report Number: 1720753-2016-02015
• Device Sequence Number: 1
• Product Code: OWB
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• 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: ES-0994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2009
• 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