MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM WORKSTATION; EXTRACORPOREAL BLOOD GAS/PH MONITOR

Model Number	QWS
Medical Device Problem Codes	Computer Software Problem (1112); Unable to Obtain Readings (1516); No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device investigation to be completed on return of device.
Event or Problem Description
User reported the device was displaying "!!!" for multiple values.Hct/sat sensor wiped clean and values factory reset, sensor replaced, hard reboots performed and the values were still alarming.Qws swapped to another hlm and it worked for a case, with errors reappearing the next day.
Additional Manufacturer Narrative
Device investigation to be completed on return of device.Final report (b)(6) 2026: hospital sensor found to have fractured fibre optic cable - accidental damage.Quantum workstation was unable to recognise the sensor in this case, however following testing on return to hq, quantum workstation functioned as expected - no fault found.Subject device preventative maintenance completed, sensor replaced.Sensor damage is not a reportable event as per company criteria.
Event or Problem Description
User reported the device was displaying "!!!" for multiple values.Hct/sat sensor wiped clean and values factory reset, sensor replaced, hard reboots performed and the values were still alarming.Qws swapped to another hlm and it worked for a case, with errors reappearing the next day.

• Brand Name: QUANTUM WORKSTATION
• Common Device Name: EXTRACORPOREAL BLOOD GAS/PH 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: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 23603250
• Report Number: 3006073153-2025-00284
• Device Sequence Number: 9444289
• Product Code: DRY
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/19/2026

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: 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: 10/22/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/17/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown