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

Model Number	QVM
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
This vmsr report summarizes malfunction events.A review of the events indicated that model qvm (product code: 51-000045-00) experienced an issue regulating vaccum (either vacuum was not available, fluctuated or was incorrect).
Additional Manufacturer Narrative
Where the event was traced to a component failure (vacuum regulator, vavd valve), the component was replaced and the device successfully tested.Where the event was traced to vavd valve wiring issue, the wiring was rerouted away from the fan, and the device successfully tested.Where the event could not be replicated, and components were not old, extensive testing was done to ensure the device operates correctly.Where components were older, they were upgraded out of precaution.The serial numbers were as follows: (b)(6).

• Brand Name: QUANTUM VENTILATION MODULE
• Common Device Name: GAS BLENDER
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: asia lukuc ; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 21282697
• Report Number: 3006073153-2025-00036
• Device Sequence Number: 12735455
• Product Code: DTX
• UDI-Device Identifier: 05060434420688
• UDI-Public: 05060434420688
• Combination Product (Y/N): N
• PMA/510(K) Number: K181942
• Exemption Number: VMSR
• Number of Events Summarized: 8
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Model Number: QVM
• Device Catalogue Number: 51-000045-00
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown