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

Model Number	QWS15S
Medical Device Problem Code	Unintended Application Program Shut Down (4032)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Logs review shows there was a pc comms loss during the reported event.During the device comms loss, gas and blood flow were not interrupted.The internal resync of comms automatically re-established all communications, by design.Upon receipt device presents no obvious signs of damage.Unable to replicate reported issue rebooting device multiple times to force communication restart.Root cause determined to be software fault.Device comms are improved in software 6.8+.Confirmed os is updated to latest version.Completed preventative maintenance successfully.As this is the second report for this error code on this serial number, device is being permanently replaced with device on site.No patient harm or delays to the surgery.
Event or Problem Description
Qws had unexpected shut-down mid-case.Power button did not appear to have been pressed for 10 seconds by user or pushing against other equipment.Qws booted back up independently with spectrum logo rotated 45 degrees and "system error" message displayed on the screen.Qws shut itself off again and booted back up properly immediately after.User was still on bypass and did not attempt a hard reboot of the qws or a swap to a new qws.All timers, record, etc.Were lost upon qws start up but no other effects to operations of the rest of the hlm.After the case logs were pulled and no reports of failure since then.

• 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 GL537-JC ; UK GL537JC
• MDR Report Key: 25123020
• Report Number: 3006073153-2026-00128
• Device Sequence Number: 8606434
• Product Code: DRY
• UDI-Device Identifier: 05060434422293
• UDI-Public: 05060434422293
• 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
• Report Date (Section B): 05/08/2026

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
• Operator of Device: Health Professional
• Device Model Number: QWS15S
• Device Catalogue Number: 51-000093-00
• 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: 04/07/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2026
• 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