MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM DIAGNOSTIC MODULE; BLOOD GAS MONITOR

Model Number	QFS4-ST-200
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	06/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer narrative awaiting conclusion of investigation.
Event or Problem Description
User reported that the arterial flow probe alerted multiple times, followed by pump stop then retrograde flow.The user could not reset the bubble stop and switched out the flow probe.Once the flow probe was switched out, the user was able to reengage flow.The user said the touchscreen was unresponsive until they switched out the flow probes.The patient was without flow for minutes.

• Brand Name: QUANTUM DIAGNOSTIC MODULE
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECRTUM MEDICAL LTD.; harrier,4 meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 19678774
• Report Number: 3006073153-2024-00008
• Device Sequence Number: 6917660
• Product Code: DRY
• UDI-Device Identifier: 05060434421876
• UDI-Public: 05060434421876
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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): 07/02/2024

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
• Device Model Number: QFS4-ST-200
• Device Catalogue Number: 51-000067-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown