MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM LEVEL SENSOR (ACCESSORY TO THE QUANTUM DIAGNOSTIC MODULE)

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	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Defective sensor to be investated on return to manufacturer.
Event or Problem Description
The safe flow remained permanently engaged and detecting fluid, even when it was not on the reservoir.No condensation/fluid or cracked housing was noted on the sensor.
Additional Manufacturer Narrative
Defective sensor to be investated on return to manufacturer.(b)(6) 2026 - follow up: device returned to manufacturer, investigation ongoing.
Event or Problem Description
The safe flow remained permanently engaged and detecting fluid, even when it was not on the reservoir.No condensation/fluid or cracked housing was noted on the sensor.
Additional Manufacturer Narrative
Defective sensor to be investigated on return to manufacturer.09-jan-2026 - follow up: device returned to manufacturer, investigation ongoing.02-feb-2026 - final: close inspection to safe level side reveals damage on housing.Unable to replicate reported fault.Sensor reacts to fluid and lack thereof as expected.Suspect potential/accidental liquid ingress that has now dried.Root cause determined to be accidental damage causing water ingress.Device replaced.
Event or Problem Description
The safe flow remained permanently engaged and detecting fluid, even when it was not on the reservoir.No condensation/fluid or cracked housing was noted on the sensor.

• Brand Name: QUANTUM LEVEL SENSOR (ACCESSORY TO THE QUANTUM DIAGNOSTIC MODULE)
• Common Device Name: LEVEL SENSOR
• 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: 23741026
• Report Number: 3006073153-2025-00292
• Device Sequence Number: 15570772
• Product Code: DRY
• UDI-Device Identifier: 05060434420893
• UDI-Public: 05060434420893
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173591
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/10/2026

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: QLV1
• Device Catalogue Number: 43-000889-00
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 11/12/2025; 11/12/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/09/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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