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 Fracture, Arm (2351)

Event Date 12/07/2016

Event Type  Injury  

Manufacturer Narrative

A ge service representative performed an onsite investigation.The workstation handle was evaluated and replaced.Ge healthcare surgery's investigation is ongoing.A follow-up report will be submitted when the investigation is completed.

Event Description

It was reported a radiologic technologist was pulling the workstation (from the workstation handle) off of a box truck when one of the four wheels got stuck in between the truck and lift gate.The radiologic technologist pulled harder on the workstation handle at which time the handle snapped free of the workstation and the employee fell off the tailgate and onto the ground.The radiologic technologist sustained a non-displaced right distal radial fracture which was treated with a closed reduction with casting.Presently the employee is without further complications related to the event.

Manufacturer Narrative

A root cause investigation was conducted in relation to the events of this complaint.The broken handle bolts were examined.Force calculations related to the bolts and handle demonstrated that the design meets the intended functionality.The investigation concluded that the handle failure was likely attributed to specific system usage outside of the recommended methods described in the operator manual and are not representative of a systemic issue with the product or design.No further actions are planned by the manufacturer at this time.

Manufacturer Narrative

The field date received by manufacturer was corrected to 12/19/2016.

• 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
• Manufacturer Contact: 384 wright brothers drive; salt lake city, UT
• MDR Report Key: 6251877
• MDR Text Key: 64883021
• Report Number: 1720753-2017-00174
• 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,Followup
• Report Date: 02/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9900
• Device Lot Number: E9-0839
• Other Device ID Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1970
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 77