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

Model Number	QVM
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Service history shows no prior issues with sat/hb log review reveals no issues/errors.Device to be investigated on return to manufacturer.
Event or Problem Description
On bypass initiation, not getting values reported for the sat/crit sensor.The problem persisted after the cable was replaced with the new bonded stock sat/crit cable.They were able to complete cases with intermittent and absent pao2 and hgb producing "!!!" -or- "---." during troubleshooting it was identified that the connection on the qws seemed to improve or temporarily restore the signal when it was manipulated.Suspecting there to be an issue with the qws data port.Happened for cases on both on (b)(6).On (b)(6): 1045-1450, on (b)(6): 1030-1130.

• 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: 24143302
• Report Number: 3006073153-2026-00005
• Device Sequence Number: 13100595
• 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
• Report Date (Section B): 01/16/2026

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: QVM
• 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: 12/19/2025
• Initial Report FDA Received Date: 01/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2019
• 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