MAUDE Adverse Event Report: SPECTRUM MEDICAL QUANTUM LEVEL SENSOR; BLOOD GAS MONITOR

Model Number	51-000078-00
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation due to be completed on return of device to spectrum medical ltd.
Event or Problem Description
User reported a difference in flow between the safe flow probe and arterial flow probe noted to be 0.5l/min at 4.0l/min of flow.This flow probe was able to be identified and swapped with a back up during the case.There was no hard to the patient involved.
Additional Manufacturer Narrative
Investigation due to be completed on return of device to spectrum medical ltd.Follow up 1: upon return of device to spectrum medical sensor shows some scratches on the housing.Investigation confirms the sensor reads out of tolerance.Sensor returned to oem for further investigation.
Event or Problem Description
User reported a difference in flow between the safe flow probe and arterial flow probe noted to be 0.5 l/min at 4.0l/min of flow.This flow probe was able to be identified and swapped with a back up during the case.There was no harm to the patient involved.

• Brand Name: QUANTUM LEVEL SENSOR
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: edward blogg ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 22466413
• Report Number: 3006073153-2025-00158
• Device Sequence Number: 8112866
• Product Code: DRY
• UDI-Device Identifier: 05060434422002
• UDI-Public: 05060434422002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173591
• 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
• Report Date (Section B): 07/10/2025

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: 51-000078-00
• Device Catalogue Number: QFS4-ST-075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/11/2025
• Supplement Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/27/2024
• 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
• Patient Sex: Unknown