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

Model Number	QVM2
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Where the event was traced to a component's failure (sensor failure, o-ring missing), the component was replaced and the device tested.Where the event was traced to calibration issue, the device was recalibrated and tested.Where event could not be replicated or the cause could not be conclusively established, the most suspected component was replaced and device tested.Serial numbers covered by this report: (b)(6).
Event or Problem Description
This vmsr report summarizes malfunction events.A review of the events indicated that module qvm2 (part number: 51-000082-00) experienced an issue when regulating gas sweep.There was no patient harm associated with these events.

• 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: 21282762
• Report Number: 3006073153-2025-00038
• Device Sequence Number: 9529326
• Product Code: DTX
• UDI-Device Identifier: 05060434422071
• UDI-Public: 05060434422071
• Combination Product (Y/N): N
• PMA/510(K) Number: K202733
• Exemption Number: VMSR
• Number of Events Summarized: 6
• 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
• Device Model Number: QVM2
• Device Catalogue Number: 51-000082-00
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Patient Sequence Number: 1
• Patient Sex: Unknown