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

Model Number	3639
Medical Device Problem Codes	Incorrect Measurement (1383); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the device has not been returned to the investigation facility to allow for an analysis to be performed.If the device is received for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event; no patient impact.
Event or Problem Description
The customer reported that the device reading[s] are inaccurate; the values were significantly lower as well as inconsistent.There was no patient impact or consequence reported.
Event or Problem Description
The customer reported that the device reading[s] are inaccurate; the values were significantly lower as well as inconsistent.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned device was evaluated.All alarm conditions were audible and visible.A foreign contaminant was found on the detector lens causing the measurements to be outside of specification.Health effect impact code: no adverse event; no patient impact.

• Brand Name: EMMA KIT
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 22901132
• Report Number: 3019388613-2025-00094
• Device Sequence Number: 8018045
• Product Code: CCK
• UDI-Device Identifier: 07350046131033
• UDI-Public: (01)07350046131033(11)221226
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2025

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: 3639
• Device Catalogue Number: 3639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/26/2022
• 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