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

Model Number	QVM
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that while using the ventilation module during a case, the vavd was inactive.There was no vacuum noted at the outlet.There was no patient harm as a result of this issue.
Additional Manufacturer Narrative
Investigation awaiting return of device to (b)(4).
Additional Manufacturer Narrative
Investigation found the root cause to be a mechanical fault with the vavd valve.The co2 adapter was also replaced.
Event or Problem Description
User reported that while using the ventilation module during a case, the vavd was inactive.There was no vacuum noted at the outlet.There was no patient harm as a result of this issue.

• 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 GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 22727831
• Report Number: 3006073153-2025-00190
• Device Sequence Number: 12834219
• Product Code: DTX
• UDI-Device Identifier: 05060434420688
• UDI-Public: 05060434420688
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K181942
• 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): 09/10/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2018
• 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