MAUDE Adverse Event Report: GE OEC MEDICAL SYSTEMS (SLC) 8800; FLUOROSCOPIC X-RAY

Model Number 8800

Device Problem Device Remains Activated (1525)

Patient Problem No Patient Involvement (2645)

Event Date 01/16/2017

Event Type  malfunction  

Manufacturer Narrative

A ge service representative performed an onsite investigation.The interconnect cable and hand switch controller were evaluated and replaced.The system was tested and found to be working as intended and returned to service.

Event Description

The customer reported that x-ray continued to be emitted after release of the hand switch.There was no report of patient involvement.There is no report of a patient injury or death associated with this event.

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 continues to deliver x-rays.The fse determined the cause of the problem to be the interconnect cable.The fse verified system functionality.The interconnect cable sends data, video and power between the workstation and the mainframe.The interconnect cable connectors are compromised of pin and receptacle connections.The receptacle on the interconnect cable is subject to repeated use, by the user, causing wear.The consistent insertion force applied to the connector housing, internal wires, and contacts are uncontrolled and wear or misalignment of contacts or housings may occur.The regular insertion and removal of the cable may damage the connector, wires, or sheath, over time.Damaged, corroded, or loose connections can cause a variety of system functionality issues and error messages.When the operator presses the x-ray button on top of the c-arm or steps on the x-ray switch, the x-ray generator detects the switch actuation and sends this information to the workstation.The system is capable of sensing system error, such as communications failure caused by open wires on the interconnect cable, and disabling fluoro function while the x-ray lamp on is indicating fluoro to the user.Based on age of the system, manufactured before 2006, this type of failure would be expected and reflective of the normal wear and tear that is anticipated as the system is used.This is not a malfunction.

• Brand Name: 8800
• 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: 6324223
• MDR Text Key: 67244893
• Report Number: 1720753-2017-00457
• Device Sequence Number: 1
• Product Code: OWB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8800
• 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: 02/14/2017
• 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