MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM LEVEL SENSOR (ACCESSORY TO THE QUANTUM DIAGNOSTIC MODULE); EXTRACORPOREAL BLOOD GAS/PH MONITOR

Model Number	QLV1
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation pending return of device to manufacturer.
Event or Problem Description
Flow level sensor head intermittently reading appropriately/not reading with led flashing on & off despite volume above level sensor head.
Additional Manufacturer Narrative
Investigation pending return of device to manufacturer.Follow up 05-jan-2026: device received, investigation of device is ongoing.
Event or Problem Description
Flow level sensor head intermittently reading appropriately/not reading with led flashing on & off despite volume above level sensor head.
Additional Manufacturer Narrative
Investigation pending return of device to manufacturer.Follow up 05-jan-2026: device received, investigation of device is ongoing.Final 04-mar-2026: upon receipt sensor presents residue accumulation in both heads.During in-house testing, sensor does not react to fluid and lack of it on safe level head.Sensor intermittently loses communication on safe level side.Holding cable in position sensor is able to communicate correctly with system.Confirmed internal wiring damage on cable between safe and protected level heads due to bend.Root cause determined to be accidental damage to internal wiring due to bend.Sensor is beyond economical repair - device replaced.
Event or Problem Description
Flow level sensor head intermittently reading appropriately/not reading with led flashing on & off despite volume above level sensor head.

• Brand Name: QUANTUM LEVEL SENSOR (ACCESSORY TO THE QUANTUM DIAGNOSTIC MODULE)
• 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: 23702950
• Report Number: 3006073153-2025-00287
• Device Sequence Number: 13422116
• Product Code: DRY
• UDI-Device Identifier: 05060434420893
• UDI-Public: 05060434420893
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173591
• Exemption Number: 287
• 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,Followup
• Report Date (Section B): 03/04/2026

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: QLV1
• Device Catalogue Number: 43-000889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Supplement Date Received by Manufacturer: 11/05/2025; 11/05/2025
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/06/2026; 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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