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

Model Number	QVM
Medical Device Problem Code	Gas Output Problem (1266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that the qvm was not showing pco2 measurement.The user tried switching out the cables but this did not resolve the issue.This happened during setup.The suspected fault was immeadiatly obvious prior to use, and there was no patient harm or delay to operation as a result of this issue.This issue was reported to ansm by the hospital.
Additional Manufacturer Narrative
Spectrum medical have requested the return of the device for an investigation.
Additional Manufacturer Narrative
The quantum ventilation unit has been reported lost by being transferred to a 3rd party.No investigation of device reportable.Spectrum medical reprisentative visited the hospital, it was noted that the users seem to be inconsistent with changing water traps (only replacing when the taps were extremely saturated) without return of the device it is not possible to determine root cause.Event initially reported as hospital had reported to ansm.
Event or Problem Description
User reported that the qvm was not showing pco2 measurement.The user tried switching out the cables but this did not resolve the issue.This happened during setup.The suspected fault was immeadiatly obvious prior to use, and there was no patient harm or delay to operation as a result of this issue.This issue was reported to ansm by the hospital.

• 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: 22563350
• Report Number: 3006073153-2025-00172
• Device Sequence Number: 9219839
• Product Code: DTX
• UDI-Device Identifier: 05060434420688
• UDI-Public: 05060434420688
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 08/05/2025

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: Health Professional
• Device Model Number: QVM
• Device Catalogue Number: 51-000045-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2022
• 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