MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM; QUANTUM DIAGNOSTIC MODULE

Model Number	QDM1
Medical Device Problem Codes	Energy Output Problem (1431); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is being returned and an investigation is ongoing.
Event or Problem Description
This issue relates to inaccurate sweep flow, which is only displaying roughly half of the value set by the gas blender.There was no patient harm and no delay to operation.This device is being returned for calibration.
Additional Manufacturer Narrative
At spectrum ltd it was confirmed air sweeps reported are very low compare to the actual input sweep and the flow reported by an external mfm.Mfm calibrated with no failure but the read calibration coefficient b is twice the value of what is expected.It is 2 and 1.Flows were checked regardless, and they are all good compared to the input sweeps.Mfm is to be replaced regardless as the calibration is not good.Root cause determined to be component failure.
Event or Problem Description
This issue relates to inaccurate sweep flow, which is only displaying roughly half of the value set by the gas blender.There was no patient harm and no delay to operation.This device is being returned for calibration.

• Brand Name: QUANTUM
• Common Device Name: QUANTUM DIAGNOSTIC MODULE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: raffaella tommasini ; commerce road; ashville business park; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 24256539
• Report Number: 3006073153-2026-00017
• Device Sequence Number: 15554352
• Product Code: DRY
• UDI-Device Identifier: 05060434420701
• UDI-Public: 05060434420701
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/23/2026

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: QDM1
• Device Catalogue Number: 51-000023-00
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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