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

Model Number	3639
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the device was received in masimo's regional facility but has been returned to the customer without an investigation per their request.If the device is returned again for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event; no patient impact.Initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (b)(6).H3 other text: product not returned.
Event or Problem Description
The customer reported that the etco2 readings were higher than expected.There was no patient impact or consequence reported.

• 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: 23528808
• Report Number: 3019388613-2025-00152
• Device Sequence Number: 13028071
• Product Code: CCK
• UDI-Device Identifier: 07350046131033
• UDI-Public: (01)07350046131033(11)200803
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2025

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
• Date Returned to Manufacturer: 10/16/2025
• 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: 10/16/2025
• Initial Report FDA Received Date: 11/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2020
• 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