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

Model Number	51-000065-00
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), service call: bea003146) to be a component fault.The fault was confirmed (serial number: (b)(6), service call: bfa00784) to be a component fault.The fault was confirmed (serial number: (b)(6), service call: bfa01318) to be a component fault.The fault was confirmed (serial number: (b)(6), service call: bfa01463) to be a component fault.In most cases, the root cause was linked to component failure.For bfa01463, the conclusion was unable to be reached as the senor was not returned, depsite a returns label being provided.
Event or Problem Description
User reported issues related to device sensing problems using sensors.Inability to correctly sense 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: 21282622
• Report Number: 3006073153-2025-00033
• Device Sequence Number: 9340285
• Product Code: DRY
• UDI-Device Identifier: 05060434421852
• UDI-Public: 05060434421852
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 51-000065-00
• Device Catalogue Number: QFS2-ST-200
• 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