MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM VENTILATION MODULE; GAS CONTROL UNIT

Model Number	QVM2-D-HM
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion awaiting completion of investigation.
Event or Problem Description
Initially the user reported "issues" with pco2 values.Service team checked the ventilation module, calibrated and downloaded the logs, and found no faults.User then reported that they were not getting airflow at the outlet.Service made a visit to the hospital and confirmed lack of flow.The service team was requested to replace the qvm and conduct tests.User reported that after qvm was replaced there were no further issues.
Additional Manufacturer Narrative
Conclusion awaiting completion of investigation.Follow-up: still awaiting return of device.
Event or Problem Description
Initially the user reported "issues" with pco2 values.Service team checked the ventilation module, calibrated and downloaded the logs, and found no faults.User then reported that they were not getting airflow at the outlet.Service made a visit to the hospital and confirmed lack of flow.The service team was requested to replace the qvm and conduct tests.User reported that after qvm was replaced there were no further issues.
Additional Manufacturer Narrative
Conclusion awaiting completion of investigation.Second follow up: initial log review indicates circuit issues on 18-mar and 27-mar.Initial investigation of device was unable to reproduce fault.Investigation still ongoing.Final review: the unit was tested on a service frame and the fault was not able to be reproduced.Log review identified circuit issues on the dates in question.When tested in-house, unit reliably produced po2 and pco2 calculations with test readings.
Event or Problem Description
Initially the user reported "issues" with pco2 values.Service team checked the ventilation module, calibrated and downloaded the logs, and found no faults.User then reported that they were not getting airflow at the outlet.Service made a visit to the hospital and confirmed lack of flow.The service team was requested to replace the qvm and conduct tests.User reported that after qvm was replaced there were no further issues.
Event or Problem Description
Initially the user reported "issues" with pco2 values.Service team checked the ventilation module, calibrated and downloaded the logs, and found no faults.User then reported that they were not getting airflow at the outlet.Service made a visit to the hospital and confirmed lack of flow.The service team was requested to replace the qvm and conduct tests.User reported that after qvm was replaced there were no further issues.
Additional Manufacturer Narrative
Conclusion awaiting completion of investigation.Second follow up: initial log review indicates circuit issues on 18-mar and 27-mar.Initial investigation of device was unable to reproduce fault.Investigation still ongoing.

• Brand Name: QUANTUM VENTILATION MODULE
• Common Device Name: GAS CONTROL UNIT
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 21941108
• Report Number: 3006073153-2025-00112
• Device Sequence Number: 13042021
• Product Code: DTX
• UDI-Device Identifier: 05060434422071
• UDI-Public: 05060434422071
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K202733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: QVM2-D-HM
• Device Catalogue Number: 51-000082-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 04/02/2025; 04/02/2025
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 05/27/2025; 06/24/2025; 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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