MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUATUM 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	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported a faulty level sensor.The yellow sensor head detects without contact and remains illuminated continuously.The red sensor head also detects and lights up, although the reservoir is free of any liquid.The replacement sensor worked as expected.There was no patient harm as a result of this suspected malfunction.
Additional Manufacturer Narrative
No fault found.Suspect the sensor heads were wetted and then dried.Sensor being replaced as a precaution.
Additional Manufacturer Narrative
Invetigation confirmed defective level sensor, intermittent connectivity issue.Faulty level sensor (b)(6) replaced with a new sensor (b)(6).Fsi completed and passed on the new sensor.
Event or Problem Description
The user reported a faulty level sensor.The yellow sensor head detects without contact and remains illuminated continuously.The red sensor head also detects and lights up, although the reservoir is free of any liquid.The replacement sensor worked as expected.There was no patient harm as a result of this suspected malfunction.

• Brand Name: QUATUM 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: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 23592150
• Report Number: 3006073153-2025-00283
• Device Sequence Number: 9924971
• Product Code: DRY
• UDI-Device Identifier: 05060434420893
• UDI-Public: 05060434420893
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 10/24/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2024
• 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