MAUDE Adverse Event Report: GAS CONTROL EQUIPMENT LTD GCE; ZEN-O

Model Number	RS-00500
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physical indicators are of an external cannula ignition that has burned back to the cannula port.:external burn to carry case elements and discoloration of the cannula port housing and oxidisation of aluminium cannula nozzle, all observed.Cause of such would be inappropriate usage by end user contrary to ifu warnings.Despite gces validation that cannula port should extinguish a cannula fire and stop it entering the device, it appears that this fire's fuel element has continued into the concentrator device and caused a continued burn back with oxygen being supplied by the device until fuel element was depleted.Evidence appears to have been somewhat affected by method of fire extinguishing performed during/after the event, with water damage to many components.Further clarification of the incident , in terms of possible external fire source, other medical devices used with the concentrator ( cannula/ mask and tube), clean up of device , fire extinguishing etc from (b)(6) and the incident's nursing home personnel.
Event or Problem Description
Report from oxygen concentrator device distributor indicates incident occuring on nursing home , (b)(6) describing 'burning battery inside the device/ burning device' and 'the patient went to eat and the mobile concentrator smoked and caught fire'.Inspection of returned device shows external signs of fire to it's carry case and burn hole through the cannula housing and carry case at that point, which would have had potential to cause harm when it occured.

• Brand Name: GCE
• Common Device Name: ZEN-O
• Manufacturer (Section D): GAS CONTROL EQUIPMENT LTD; 100 empress park, penny lane; haydock; st helens, merseyside WA11 9DB; UK WA11 9DB
• Manufacturer (Section G): GCE S.R.O.; zizkova 381; chotebor, 583 0 1; EZ 583 01
• Manufacturer Contact: michael shaw ; 100 empress park, penny lane; haydock; st helens, merseyside WA11 -9DB ; UK WA11 9DB
• MDR Report Key: 23016051
• Report Number: 3011895992-2025-00004
• Device Sequence Number: 18598188
• Product Code: CAW
• UDI-Device Identifier: 08592346004337
• UDI-Public: 08592346004337
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K162433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: RS-00500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown