MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD SYSTEM M; GAS MODULE (HIGH FLOW)

Catalog Number	3003-030-010
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The vco2 is always around 100, which is a completely inaccurate value (normal <70).The problem doesn't seem to originate from the exhaled co2 sensor, as the value retrieved from the new essenz console is correct.The problem therefore appears to be with the monitor itself (a vco2 calculation issue?).The second problem concerns the pao2 calculation.The reading drifts significantly over time.(we perform arterial blood gas analysis every 30 minutes to recalibrate the spectrum.The arterial pao2 reading is always very different from the pao2 displayed on the spectrum.).
Additional Manufacturer Narrative
Device being returned.Manufacturer's conclusion to follow.
Additional Manufacturer Narrative
The device was returned and an investigation found the following.No visual issues seen.The module was investigated tested and calibrated.It was found that the external co2 sensor failed co2 spec.4% was 6.3% and 9% was 13.16%.O2 readings were also too low and out of spec.100% was 96% and less at times.Attempted o2 and co2 calibration, and also a full gas sweep and pressure calibration but this made no difference.No pressure leaks were detected.Whether this has any bearing on the reported fault is not known.The o2 sensor is now obsolete and not available.The module is to be scrapped.The o2 sensor and external outlet co2 sensor have been replaced.Calibrated, tested and pm passed.
Event or Problem Description
The vco2 is always around 100, which is a completely inaccurate value (normal <70).The problem doesn't seem to originate from the exhaled co2 sensor, as the value retrieved from the new essenz console is correct.The problem therefore appears to be with the monitor itself (a vco2 calculation issue?).The second problem concerns the pao2 calculation.The reading drifts significantly over time.(we perform arterial blood gas analysis every 30 minutes to recalibrate the spectrum.The arterial pao2 reading is always very different from the pao2 displayed on the spectrum.).

• Brand Name: SYSTEM M
• Common Device Name: GAS MODULE (HIGH FLOW)
• 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 ; RE GL29SL
• MDR Report Key: 24429177
• Report Number: 3006073153-2026-00029
• Device Sequence Number: 16050460
• Product Code: DRY
• UDI-Device Identifier: 05060434420190
• UDI-Public: 05060434420190
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K110957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Catalogue Number: 3003-030-010
• 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: 02/11/2026
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2018
• 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