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	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial investigation is still ongoing.
Event or Problem Description
Customer did a bypass with fio2 of 60% and normal sweep.No physiologic activated or any autoregulation.Perfusionist thought that blood was dark.But po2 on qws showed 500 mmhg, so very high.Bloodgas showed a initial po2 of 90 mmhg so a very big discrepancy.Then raised the fio2, but that didnt solve much.So decided to switch to external back up gasblender with y connection (due to dual chamber).Upon query asked spectrum oxy was not activated.Engineer activated it in settings.Customer decided to go back to ventilation with qvm and they finished the case without damage to the patient.
Additional Manufacturer Narrative
Investigation is still ongoing.However, preliminary findings show that just before going on bypass someone disabled, enabled and in the end disabled the spectrum oxy functionallity which resulted in only ventilation on the 40% green chamber of the spectrum oxy.Which resulted in the mentioned low po2, but the faulty calculation of po2 on the qws.A further follow up investigation will determine the root cause.
Event or Problem Description
Customer did a bypass with fio2 of 60% and normal sweep.No physiologic activated or any autoregulation.Perfusionist thought that blood was dark.But po2 on qws showed 500 mmhg, so very high.Bloodgas showed showed a initial po2 of 90 mmhg so a very big discrepancy.Then raised the fio2, but that didnt solve much.So decided to switch to external back up gasblender with y connection (due to dual chamber).Upon query asked spectrum oxy was not activated.Engineer activated it in settings.Customer decided to go back to ventilation with qvm and they finished the case without damage to the patient.

• 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: 24188086
• Report Number: 3006073153-2026-00010
• Device Sequence Number: 15427277
• Product Code: DTX
• UDI-Device Identifier: 05060434422064
• UDI-Public: 05060434422064
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Followup,Followup
• Report Date (Section B): 05/21/2026

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; 01/16/2026; 01/16/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/24/2026; 04/24/2026; 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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