MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM; QUANTUM VENTILATION MODULE

Model Number	QVM2-N-HM
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation opened to determine the cause of the incident.Conculsions to follow in follow-up report.
Event or Problem Description
Customer contacted to say they have experienced an unusual event during case.The customer stated that they went onto bypass, arterial sat alarming at 90% and the qvm2 po2 reading 55, they cleaned the probe and checked gas on external analyser which displayed 9.They then turned sweep up 8-10lpm and mentioned pco2 = 6 and po2 = 40+.They have ran majority of the case with high sweep valves and noticed fluctuations pco2 and po2.They have increased the sweep to 15lpm and then reported that the black cap on the co2 port was blown off the qvm and they were able to feel air exiting it.They have mentioned pco2 and po2 was inaccurate.They have also expressed that the wag flow was incorrect, at 15lpm sweep wag flow was 10.4lpm.There was no patient harm and no reported delay to surgery.
Event or Problem Description
Customer contacted to say they have experienced an unusual event during case.The customer stated that they went onto bypass, arterial sat alarming at 90% and the qvm2 po2 reading 55, they cleaned the probe, and checked gas on external analyser which displayed 9.They then turned sweep up 8-10lpm and mentioned pco2 = 6 and po2 = 40+.They have ran majority of the case with high sweep valves, and noticed fluctuations pco2 and po2.They have increased the sweep to 15lpm and then reported that the black cap on the co2 port was blown off the qvm and they were able to feel air exiting it.They have mentioned pco2 and po2 was inaccurate.They have also expressed that the wag flow was incorrect, at 15lpm sweep wag flow was 10.4lpm.There was no patient harm and no reported delay to surgery.
Additional Manufacturer Narrative
Investigation into this issue was conuducted by log and csv analysis.Log analysis shows no errors related to the qvm.No software or hardware issue.Csv analysis shows clear sign of condensation in the oxygenator.Appropriate sao2 and svo2 values, therefore, the oxygenator was oxygenating.Increase in sweep did not change pco2.This indicates that the oxy fibres were saturated, affecting co2 removal.The qvm worked as expected.The customer was asked to perform a gas calibration and testing the qvm at different sweep and fio2 values.They confirmed gas calibration was successful and no alarms or alerts occurred during the subsequent tests.

• Brand Name: QUANTUM
• Common Device Name: QUANTUM VENTILATION MODULE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: raffaella tommasini ; commerce road; ashville business park; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 24188319
• Report Number: 3006073153-2026-00011
• Device Sequence Number: 7894164
• Product Code: DTX
• UDI-Device Identifier: 05060434422064
• UDI-Public: 05060434422064
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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-HM
• Device Catalogue Number: 51-000081-00
• 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: 01/16/2026
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown