MAUDE Adverse Event Report: WSO GE MEDICAL SYSTEMS, LLC OPTIMA XR220; SYSTEM, X-RAY, MOBILE

Model Number 5555000-5

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Device Maintenance Issue (1379); Device Slipped (1584); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2017

Event Type  malfunction  

Manufacturer Narrative

Ge healthcare's investigation into the reported event is still ongoing.A follow-up report will be issued when the investigation has been completed.Device evaluation anticipated, but not yet begun.

Event Description

On (b)(6) 2017, the ge healthcare field engineer (fe) was performing service on an optima xr220 mobile device at (b)(6) hospital and as he was tightening screws to the high voltage cabling, the wrench slipped from his hand and landed across the battery terminal leads on the cricket board.The result was a thermal event with smoke and a fire with approximately eighteen inch flames.A fire extinguisher was used to extinguish the thermal event.The thermal event did not spread to the exterior of the mobile device.There was no injury related to this event.

Manufacturer Narrative

The ge healthcare investigation has been completed and the root cause of this event was determined to be a service error as the ge field service engineer did not perform the lock out tag out (loto) procedure prior to servicing the mobile device.Per the optima xr200/220amx exclusive system service manual direction 5336120-1en revision 16, the loto procedure should be completed whenever servicing the device.As a correction, the ge field engineer was reminded to always follow the loto procedure prior to servicing any device in addition to using the appropriate personnel protective equipment and insulated tools when applicable.No further actions are needed.

• Brand Name: OPTIMA XR220
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): WSO GE MEDICAL SYSTEMS, LLC; 3000 north grandview blvd.; waukesha WI
• Manufacturer Contact: steven walczak ; 3000 north grandview boulevard; waukesha, WI
• MDR Report Key: 6450467
• MDR Text Key: 71588231
• Report Number: 2126677-2017-00003
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5555000-5
• Other Device ID Number: UDI NOT REQUIRED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2017
• 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: N
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 123