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

Model Number	QFS4-ST-075
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was tested on return to the manufacturer.Failed mode confirmed.On internal inspection, a green sensor wire had snapped off the solder bucket.The root cause was determined to be due to failed solder joints.
Event or Problem Description
It was reported that the the bubble detector triggered after the user had finished priming.As no air was visible, this was treated as a false positive.There was no harm to the patient involved.We consider incorrect measurement from bubble sensor to be reportable.

• Brand Name: QUANTUM FLOW 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: 22235924
• Report Number: 3006073153-2025-00145
• Device Sequence Number: 9042082
• Product Code: DRY
• UDI-Device Identifier: 05060434422002
• UDI-Public: 05060434422002
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 06/17/2025

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: QFS4-ST-075
• Device Catalogue Number: 51-000078-00
• Device Lot Number: FS4000211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2021
• 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