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

Model Number	QVM2-N-HM
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The quantum ventilation module units were functioning as expected; however, when the level sensor was connected to the qvm, it failed to operate properly.When the protected/safe level safety was engaged, the led on the level sensor did not illuminate when fluid was present.
Additional Manufacturer Narrative
The device is being returned and an investigation is ongoing.
Event or Problem Description
The quantum ventilation module units were functioning as expected; however, when the level sensor was connected to the qvm, it failed to operate properly.When the protected/safe level safety was engaged, the led on the level sensor did not illuminate when fluid was present.
Additional Manufacturer Narrative
Preliminary results showed that with no level sensor connected, the system displays level 2 on qws and spt.When the level sensor is connected, the system displays level 0, and no light is emitted from the sensor.This indicates a potential fault with the pcba - fpl.Root cause and investigation summary with follow in final report.
Event or Problem Description
The quantum ventilation module units were functioning as expected; however, when the level sensor was connected to the qvm, it failed to operate properly.When the protected/safe level safety was engaged, the led on the level sensor did not illuminate when fluid was present.
Additional Manufacturer Narrative
Preliminary results showed that with no level sensor connected, the system displays level 2 on qws and spt.When the level sensor is connected, the system displays level 0, and no light is emitted from the sensor.This indicates a potential fault with the pcba - fpl.The device has now been returned and the root cause and investigation summary will follow in a final report.

• 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: 24256302
• Report Number: 3006073153-2026-00016
• Device Sequence Number: 8346341
• Product Code: DTX
• UDI-Device Identifier: 05060434422064
• UDI-Public: 05060434422064
• 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,Followup,Followup
• Report Date (Section B): 05/26/2026

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: 01/23/2026
• Supplement Date Received by Manufacturer: 01/23/2026; 01/23/2026; 01/23/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/26/2026; 04/28/2026; 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/07/2025
• 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