MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM RESERVOIR 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	08/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that the level sensor did not respond as expected to detect fluid.There was no patient harm; however, level sensor errors are considered reportable by spectrum medical.
Additional Manufacturer Narrative
Investigation is pending the return of the device to spectrum medical.
Additional Manufacturer Narrative
Investigation is pending the return of the device to spectrum medical.
Event or Problem Description
User reported that the level sensor did not respond as expected to detect fluid.There was no patient harm; however, level sensor errors are considered reportable by spectrum medical.
Additional Manufacturer Narrative
Investigation is pending the return of the device to spectrum medical.
Event or Problem Description
User reported that the level sensor did not respond as expected to detect fluid.There was no patient harm; however, level sensor errors are considered reportable by spectrum medical.
Event or Problem Description
User reported that the level sensor did not respond as expected to detect fluid.There was no patient harm; however, level sensor errors are considered reportable by spectrum medical.
Additional Manufacturer Narrative
Investigation is pending the return of the device to spectrum medical.
Additional Manufacturer Narrative
Device was lost on site and not able to be returned for investigation.
Event or Problem Description
User reported that the level sensor did not respond as expected to detect fluid.There was no patient harm; however, level sensor errors are considered reportable by spectrum medical.

• Brand Name: QUANTUM RESERVOIR 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: 22976315
• Report Number: 3006073153-2025-00233
• Device Sequence Number: 15696407
• Product Code: DRY
• UDI-Device Identifier: 05060434420893
• UDI-Public: 05060434420893
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup,Followup
• Report Date (Section B): 12/19/2025

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 08/05/2025; 08/05/2025; 08/05/2025
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 10/03/2025; 10/31/2025; 11/26/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2024
• 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