MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM FLOW SENSOR (ACCESSORY TO THE QUANTUM DIAGNOSTICS MODULE); BLOOD GAS MONITOR

Model Number	QFS1-ST-200
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During investigation, it was found that: the fault was confirmed (serial number: (b)(6)) to be a component fault.The fault was confirmed (serial number: (b)(6)) to be a component fault.The fault was confirmed (serial number: (b)(6)) to be a component fault.The fault was not able to be reproduced (serial number: (b)(6)).In all cases, the root cause was not able to be established.
Event or Problem Description
User reported issues related to device sensing problems using sensors.Incorrect measurement or failure to detect gross emboli is considered a reportable event.There was no patient harm as a result of these malfunctions.

• Brand Name: QUANTUM FLOW SENSOR (ACCESSORY TO THE QUANTUM DIAGNOSTICS MODULE)
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: edward blogg ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 21282645
• Report Number: 3006073153-2025-00034
• Device Sequence Number: 7908421
• Product Code: DRY
• UDI-Device Identifier: 05060434421845
• UDI-Public: 05060434421845
• Combination Product (Y/N): N
• PMA/510(K) Number: K173591
• Exemption Number: VMSR
• 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): 01/30/2025

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: QFS1-ST-200
• Device Catalogue Number: 51-000064-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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