MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY IRMA CO2; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number	4748
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: masimo has reached out to the customer to request the return of the device.The device has not been returned to masimo to allow an analysis to be performed.If the device is returned for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event, no patient impact.E1.Initial reporter zip code exceeded allowable field length, initial reporter zip code is as follows: (b)(4).H3 other text: product not returned.
Event or Problem Description
The customer reported the irma " values are showing high.Etco2 values showing above 45 and fico2 values showing above 6." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the returned device was evaluated.During evaluation the device passed visual inspection.During functional testing, the device triggered a "motor speed out of bounds" error when the airway adapter was installed, this was due to a defective detector filter wheel.Accuracy testing could not be performed on the device due to the "motor speed out of bounds" error preventing the device from obtaining readings.E1.Initial reporter zip code: (b)(6).Health effect impact code: no adverse event, no patient impact.
Event or Problem Description
The customer reported the irma " values are showing high.Etco2 values showing above 45 and fico2 values showing above 6." there was no patient impact or consequence reported.

• Brand Name: IRMA CO2
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): MASIMO - 15750 ALTON PKWY; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: rishi jain ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 23460326
• Report Number: 3019388613-2025-00143
• Device Sequence Number: 15724534
• Product Code: CCK
• UDI-Device Identifier: 07350046131675
• UDI-Public: (01)07350046131675(11)240416
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K123043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2025

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: 4748
• Device Catalogue Number: 4748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown