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	Hypoxia (1918)
Date of Event	06/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that during the case sweep dropped to 2.9 l and fio2 dropped to 21%.User switched out the qvm as they were unable to control the gas with the qvm.Following the case the qvm was successfully calibrated with out it resolving the issue.Water traps were changed as moisture was found towards the qvm side.There were no reports of long-term health consequences to the patient.
Additional Manufacturer Narrative
Spectrum medical have requested the return of the device for an investigation.
Additional Manufacturer Narrative
User reported that during the case sweep dropped to 2.9 l and fio2 dropped to 21%.User switched out the qvm as they were unable to control the gas with the qvm.Following the case the qvm was successfully calibrated with out it resolving the issue.Water traps were changed as moisture was found towards the qvm side.There were no reports of long term health consequences to the patient.
Event or Problem Description
User reported that during the case sweep dropped to 2.9 l and fio2 dropped to 21%.User switched out the qvm as they were unable to control the gas with the qvm.Following the case the qvm was successfully calibrated with out it resolving the issue.Water traps were changed as moisture was found towards the qvm side.There were no reports of long term health consequences to the patient.

• 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: 22563328
• Report Number: 3006073153-2025-00173
• Device Sequence Number: 9348024
• 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): 08/15/2025

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?: Yes
• Date Returned to Manufacturer: 07/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 07/22/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2020
• 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