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

Model Number	QVM2-D-HM
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has been returned.Root cause determination is pending the completion of an investigation.
Event or Problem Description
User reported that the ventilation module turned off twice during use, which is considered reportable by spectrum medical.There was no patient harm.
Event or Problem Description
User reported that the ventilation module turned off twice during use, which is considered reportable by spectrum medical.There was no patient harm.
Additional Manufacturer Narrative
Investigation could not replicate the reported fault; however, during internal inspection of the device, it was discovered that the ui board was loose.The loss of communication to this board does not interrupt gas or setpoints, so there was no risk of patient harm.After repair, the unit was confirmed to operate as expected.

• Brand Name: QUANTUM VENILATION MODULE
• Common Device Name: VENTILATION MODULE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: cameron schmitt ; 481 munn road; suite 180; fort mill, SC 29715
• MDR Report Key: 24109422
• Report Number: 3006073153-2026-00006
• Device Sequence Number: 14922512
• Product Code: DTX
• UDI-Device Identifier: 05060434422071
• UDI-Public: 05060434422071
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• 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: Repair
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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-D-HM
• Device Catalogue Number: 51-000082-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2025
• Supplement Date Received by Manufacturer: 12/20/2025
• Initial Report FDA Received Date: 01/19/2026
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/19/2022
• 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