MAUDE Adverse Event Report: GE MEDICAL SYSTEMS, LLC OPTIMA XR200; SYSTEM, X-RAY, MOBILE

Model Number 5555000

Device Problems Thermal Decomposition of Device (1071); Fire (1245); Smoking (1585); Battery Problem (2885)

Patient Problems Unspecified Respiratory Problem (4464); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020, the ge field engineer (fe) arrived at (b)(6) in (b)(6) to investigate an optima xr200 mobile x-ray device where the customer reported smelling a burning aroma from the system two days prior.When the fe plugged the mobile system into the hospital electrical outlet, the system started emitting smoke, so the fe immediately unplugged the device.Upon further investigation when the fe removed the system cover, a flame was ignited.The hospital fire alarm was activated, and the customer used a fire extinguisher to extinguish the fire.The fe involved in this incident did experience some mild upper respiratory tract irritation due to smoke inhalation that was temporary and self-resolving aided with over the counter anti-inflammatory medication.

Manufacturer Narrative

Ge healthcares investigation has been completed and the root cause of the issue was determined to be an internal crack within the battery case although the cause of the crack could not be determined.The ge field engineer (fe) arrived at the site to investigate the system and when plugged into the wall socket, smoke started to be emitted from the system cabinet.The fe unplugged the system from the wall socket and removed the system cabinet cover to investigate further.As the cover was removed, arcing/flames were initiated and immediately extinguished using a fire extinguisher.The fe determined the thermal event was initiated inside the battery compartment and did not spread to other internal subsystems.An attempt was made to have the batteries returned for additional analysis, but they were not allowed to pass through customs.The most probable cause is the battery case became cracked leaking battery acid and then during the charge cycling, the crack become larger and the battery acid leakage became exaggerated.And then when the battery acid contacts the metal battery compartment, it can short to ground and result in smoking/arcing.A ge service representative provided a quote to fix the system, but it was refused by the customer.No further actions are needed.

• Brand Name: OPTIMA XR200
• Type of Device: SYSTEM, X-RAY, MOBILE
• Manufacturer (Section D): GE MEDICAL SYSTEMS, LLC; 3000 n grandview blvd.; waukesha, WI 53188
• MDR Report Key: 10793533
• MDR Text Key: 216832947
• Report Number: 2126677-2020-00010
• Device Sequence Number: 1
• Product Code: IZL
• Combination Product (y/n): N
• PMA/PMN Number: K103476
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5555000
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 54