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

Model Number	QFS5-ST-075
Medical Device Problem Code	Incorrect Interpretation of Signal (1543)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion awaiting culmination of investigation.
Event or Problem Description
User reported that during the set up the venous flow sensor was showing flow whilst the line was clamped and there was no flow.During the procedure the sensor stopped working.

• Brand Name: QUANTUM FLOW SENSOR
• Common Device Name: MONITOR BLOOD GAS
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 20629875
• Report Number: 3006073153-2024-00089
• Device Sequence Number: 17978457
• Product Code: DRY
• UDI-Device Identifier: 05060434422019
• UDI-Public: 05060434422019
• 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): 11/04/2024

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: QFS5-ST-075
• Device Catalogue Number: 51-000079-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 11/07/2024
• Date Device Manufactured: 02/05/2021
• 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