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

Model Number	QWS
Medical Device Problem Codes	Computer Software Problem (1112); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that the pressure regulation failed on their device.The device was continued to be used to complete the case successfully, with no harm to the patient involved.
Additional Manufacturer Narrative
Device investigation to be completed on return of device.
Additional Manufacturer Narrative
Clinical setup reviewed and found that the occlusion of the circuit was very tight.Reported behaviour reproduced in lab.Due to low flow and low pressure conditions caused by occlusion, the pump was responding in fast mode algorithm.System worked as intended.
Event or Problem Description
User reported that the pressure regulation failed on their device.The device was continued to be used to complete the case successfully, with no harm to the patient involved.

• Brand Name: QUANTUM WORKSTATION
• Common Device Name: BLOOD GAS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: angus fletcher ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 22553219
• Report Number: 3006073153-2025-00169
• Device Sequence Number: 9637834
• Product Code: DRY
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K163657
• 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,Followup
• Report Date (Section B): 08/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: QWS
• Device Catalogue Number: 51-000001-00
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2020
• 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