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	09/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device being returned to manufacturer, to be investigated on return.
Event or Problem Description
User contacted spectrum because of a significant variation in fio2 and sweep flow observed during the case, and a gas outlet alarm was noted.Device was put on the side for review.No patient harm reported and no impact to patient safety.
Additional Manufacturer Narrative
Device being returned to manufacturer, to be investigated on return.Follow up 25-nov-2025: due to circumstances beyond our control, the device has not been received yet.Investigation will commence when the device arrives at hq.
Event or Problem Description
User contacted spectrum because of a significant variation in fio2 and sweep flow observed during the case, and a gas outlet alarm was noted.Device was put on the side for review.No patient harm reported and no impact to patient safety.

• 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: sohib maskin ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 23252656
• Report Number: 3006073135-2025-00253
• Device Sequence Number: 13316697
• 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): 11/25/2025

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: 09/25/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/24/2018
• 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