MAUDE Adverse Event Report: GAS CONTROL EQUIPMENT 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	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device nearly 2 years old with only 35hrs runtime.No signs of any inappropriate handling damage or contamination.Error log has 32x6 (low battery) and 23x4 (checkvents/low purity) messages recorded.Excessive discharge of battery energy at the +, c and d terminals of battery connector, which appears centered on the battery board, under 5 pin battery connector.Heat caused even the legs of the three connector contacts to be melted.Xray found no shorting element in battery connector.Board is burned away and heat and fumes have caused damage to surrounding plastics (melted and or discoloured).Battery indicates no residual charge.Battery board trackability record in improbity was found to be wrong (copy of motherboard s/n!) but, based on devices manufactured at same time, battery board batch determined to be (b)(6).Symptoms indicate causes are potentially: 1) board defect (solder /track insulation) causing short circuit between + and either c or d terminal at the battery board layers 2) physical damage to battery board inhouse or by user causing short circuit.3) conductive foreign object across battery terminals allowing/initiating electrical return path (short circuit) to battery electronics damage defeating internal battery protection circuitry further allowing battery energy to be dissipated in the created circuit.No further feedback from customer or end user/patient other than no harm caused.Assembly sent to battery manufacturer but no further identified potential causes were identified by them.Samples of same batch of battery board were inspected, but no defect observed.
Event or Problem Description
French customer (not end user/patient) described 'battery fire' with photographs which were not detailed enough to determine severity.Device (b)(6) and battery was returned to czech repair site where first inspection suggested categorise high severity for further investigation.Device and battery were sent to legal manufacturer un uk for furhther investigation.Device nearly 2 years old with only 35hrs runtime.No signs of any inappropriate handling damage or contamination.Error log has 32x6 (low battery) and 23x4 (checkvents/low purity) messages recorded.Excessive discharge of battery energy at the +, c and d terminals of battery connector, which appears centered on the battery board, under 5 pin battery connector.Heat caused even the legs of the three connector contacts to be melted.Xray found no shorting element in battery connector.Board is burned away and heat and fumes have caused damage to surrounding plastics (melted and or discoloured).Battery indicates no residual charge.Battery board trackability record in improbity was found to be wrong (copy of motherboard s/n!) but, based on devices manufactured at same time, battery board batch determined to be (b)(6).Findings and severity with potential to cause harm, device deemed reportable incident.Appears to be isolated incident as no similar cases in the fielded population (tens of thousands) have been recorded.

• Brand Name: GCE
• Common Device Name: ZEN-O LITE
• 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: 21993674
• Report Number: 3011895992-2025-00001
• Device Sequence Number: 4287845
• Product Code: CAW
• UDI-Device Identifier: 08592346658110
• UDI-Public: 08592346658110
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/08/2025

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: 01/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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