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	06/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Physical inspection of the returned unit , recorded discolouration of external plastics and pitting and marking of the aluminium cannula port indicating the device has been subject to a cannula fire which can only be caused by excessive heat such as flame , lit cigarette , or electric fire igniting the end of the applied nasal cannula whilst device was running in continuous mode.This is use contrary to the indicated warning signs on the device and in the instructions for use.The cannula fire would have burned back over several seconds - contrary to the ' explosion' description of the user.The fire did manage to jump the aluminium (no fuel) cannula male and continue inside the device ,but did not cause other external excess heat outside the body of the device.No explanation for soot on the ac power connection plug could be identified and the power connector is on complete other side of device to the cannula port.Further clarification of the incident circumstances have been requested from those present during the incident.
Event or Problem Description
User reported ''i'd been out and was about to charge the oxygen concentrator on my return home.A friend of the patient plugged the charger into the zen-o and when she plugged it into the wall socket - or moved the plug in the socket - there was a loud bang and a burst of flame shot out from the oxygen concentrator.It was a huge shock for the ladies.According to the assistive technology centre technician who went there and replaced the concentrator with a new one, it looks as though a "[?]"gas explosion' had taken place inside the machine.There were black marks all round and on the plug and connector." event occured in sweeden and was reported to the swedish nca - swedish medical products agency (b)(6).No one was harmed, however customer considered there was potential to have caused harm.
Event or Problem Description
User reported ''i'd been out and was about to charge the oxygen concentrator on my return home.A friend of the patient plugged the charger into the zen-o andwhen she plugged it into the wall socket - or moved the plug in the socket - there was a loud bang and a burst of flameshot out from the oxygen concentrator.It was a huge shock for the ladies.According to the assistive technology centre technician who wentthere and replaced the concentrator with a new one, it looks as though a "[?]"gas explosion' had taken place inside the machine.There were black marks all round and onthe plug and connector." event occured in sweeden and was reported to the swedish nca - swedish medical products agency (läkemedelsverket).No one was harmed , however custoemr considered there was potential to have caused harm.
Additional Manufacturer Narrative
Physical inspection of the returned unit , recorded discolouration of external plastics and pitting and marking of the aluminium cannula port indicating the device has been subject to a cannula fire which can only be caused by excessive heat such as flame , lit cigarette , or electric fire igniting the end of the applied nasal cannula whilst device was running in continuous mode.This is use contrary to the indicated warning signs on the device and in the instructions for use.The cannula fire would have burned back over several seconds - contrary to the ' explosion' description of the user.The fire did manage to jump the aluminium (no fuel) cannula male and continue inside the device ,but did not cause other external excess heat outside the body of the device.No explanation for soot on the ac power connection plug could be identified and the power connector is on complete other side of device to the cannula port.Further clarification of the incident circumstances and condition of was requested from the health care facility and present during the incident., however no further contributory information was forthcoming.As such root cause is believed to be user misuse.

• 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: 25822511
• Report Number: 3011895992-2026-00002
• Device Sequence Number: 21428442
• Product Code: CAW
• UDI-Device Identifier: 08592346004337
• UDI-Public: 08592346004337
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K162433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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?: Yes
• Date Returned to Manufacturer: 06/28/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: 06/16/2026
• Initial Report FDA Received Date: 07/15/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2026
• 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