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

Model Number	RS-00500
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Device was returned to repair center with no information and was missing batteries and battery cover.Melted hole in the rear of the device was observed.Disassembly and further inspection showed additional melting of the bottom of it's battery compartment indicating that excessive heat was generated within the rear battery pack.Evidence of smoke/fumes having exited the device was also observed.Although no report of harm caused to user/patient , high temperature event is considered to have potential to cause harm.
Additional Manufacturer Narrative
Device was returned with no information and was missing batteries and battery cover.Inspection found device to still power up with external power application showing it had only run 17 hrs despite being manufactured in july 2019.Device is outside it's service life (5 years).It is unknown at this point if event occured within service life or not.Disassembly and further inspection showed melting of the rear cover and bottom of it's battery compartment indicating that the heat was generated within the rear battery pack.Parts of the battery label were heat welded to the inside of the battery compartment and the rear battery had been levered out of the compartment as indicated by the rear frame deformations around the entrance aperture.Battery board, although covered in metalic fume coating and melted plastics otherwise looked intact.Dark liquid runs from the melted area seen.Batteries were requested from returning customer (oxygen salud s.A.(spain)), but we are informed batteries were scrapped in spain (no physical evidence or photos available).Without the batteries no further evaluation / root cause investigation could be made.It is suspected that the batteries may well have deteriorated due to lack of use over years and/or when attempted to be used responded adversely.No root cause could be identified due to lack of evidence.Manufacturer is not aware of any similar failures of this medical device.

• 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: 21993760
• Report Number: 3011895992-2025-00002
• Device Sequence Number: 4287857
• Product Code: CAW
• UDI-Device Identifier: 08592346004337
• UDI-Public: 08592346004337
• 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: Other,Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

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: Lay User/Patient
• Device Model Number: RS-00500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2019
• 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