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

Model Number	RS-00600
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During servicing the device's internal inspection found battery board overheating and burned surfaces with evidence of some smoke generation.Device zl306340 manufactured 07/2/2023 however on receipt at service center had only 8 hrs runtime which would have been mostly factory running prior to sale.Effectively unused device after nearly 2 1/2 years.Battery power dissipated at the battery cable connection to the battery board due to some form of short circuit.320 ohm remains between + and - battery connection terminals even after burning of the board.Post base replacement , device ran 1hr 35mins on full battery, (ifu 1hr 30 mins guide) indicating no other issue with the device.Environment caused furring of solder joints or foreign object short circuit of battery terminals or defect in battery board are possible causes but not wholly identifiable from the remaining material.Only one similar incident ever previously observed of similar age and lack of actual use.
Event or Problem Description
Device returned for service with no reference to being a device of special interest or any significant/adverse event occurring with it, by customer - (b)(6).During servicing the device's internal inspection found battery board overheating and burned surfaces with evidence of some smoke generation.Believe incident occurred whilst device was in (b)(6).Potential to have cause harm determined by repair facility in czech republic.

• Brand Name: GCE
• Common Device Name: ZEN-O LITE
• Manufacturer (Section D): GAS CONTROL EQUIPMNET 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: 22606964
• Report Number: 3011895992-2025-00003
• Device Sequence Number: 20198278
• Product Code: CAW
• UDI-Device Identifier: 08592346658110
• UDI-Public: 8592346658110
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K162433
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2025

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-00600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2025
• Initial Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown