MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM LEVEL SENSOR; LEVEL SENSOR ASSEMBLY

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	11/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is awaiting return of the device.
Event or Problem Description
User reported that the level sensor did not trigger an alert to indicate a lack of fluid.This is considered a reportable event as there is potential for serious patient harm to occur if the reservoir were to empty without the user realizing.There was no patient harm in this instance.
Additional Manufacturer Narrative
Device has been returned.Root cause determination is pending results of the investigation.
Event or Problem Description
User reported that the level sensor did not trigger an alert to indicate a lack of fluid.This is considered a reportable event as there is potential for serious patient harm to occur if the reservoir were to empty without the user realizing.There was no patient harm in this instance.
Additional Manufacturer Narrative
Investigation was unable to replicate the reported event; however, due to potential intermittent issues, sensor was scrapped.
Event or Problem Description
User reported that the level sensor did not trigger an alert to indicate a lack of fluid.This is considered a reportable event as there is potential for serious patient harm to occur if the reservoir were to empty without the user realizing.There was no patient harm in this instance.

• Brand Name: QUANTUM LEVEL SENSOR
• Common Device Name: LEVEL SENSOR ASSEMBLY
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: cameron schmitt ; 481 munn road; suite 180; fort mill, SC 29715
• MDR Report Key: 23789673
• Report Number: 3006073153-2025-00304
• Device Sequence Number: 14845556
• Product Code: DRY
• UDI-Device Identifier: 05060434420893
• UDI-Public: 05060434420893
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/06/2026

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
• Device Lot Number: QLV1000390
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 12/12/2025; 12/12/2025
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/09/2026; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/12/2024
• 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