MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM LEVEL SENSOR

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	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that the level sensor was not triggering the expected response.The user replaced the level sensor.There was no patient harm.
Additional Manufacturer Narrative
Upon return of the device, the sensor was connected to a service heart-lung machine.The sensor did not respond to stimuli at all.The cause was traced to failure of the component.

• Brand Name: QUANTUM LEVEL SENSOR
• Common Device Name: LEVEL SENSOR
• 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: 25504032
• Report Number: 3006073153-2026-00154
• Device Sequence Number: 21463938
• Product Code: DRY
• UDI-Device Identifier: 05060434420893
• UDI-Public: 05060434420893
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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
• Report Date (Section B): 06/12/2026

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: QLV1000395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2024
• 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