MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QVM2-N-TM - QUANTUM VENTILATION MODULE; CARDIOPULMONARY BYPASS SYSTEM GAS CONTROL UNIT

Model Number	QVM2-N-TM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
User reported a problem with the vavd, the setpoint is not hold and come back to 0.Spectrum employee went on site to test unit.The qvm does not hold the setpoint and show error 600.
Additional Manufacturer Narrative
Report submitted following review of worldwide complaints determined this report was missed from reporting to the fda.No patient health and safety impact or delays to surgeries.

• Brand Name: QVM2-N-TM - QUANTUM VENTILATION MODULE
• Common Device Name: CARDIOPULMONARY BYPASS SYSTEM 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: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 24838563
• Report Number: 3006073153-2026-00106
• Device Sequence Number: 6145647
• Product Code: DTX
• UDI-Device Identifier: 05060434422743
• UDI-Public: 05060434422743
• 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
• Report Date (Section B): 04/10/2026

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: QVM2-N-TM
• Device Catalogue Number: 51-000102-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2021
• 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