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

Model Number	3639
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
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.E1.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).Health effect impact code: no adverse event; no patient impact.H3 other text: product not returned.
Event or Problem Description
The customer reported that the device power[ed] off by itself.There was no patient impact or consequence reported.
Event or Problem Description
The customer reported that the device power[ed] off by itself.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other text: the returned device was evaluated.During evaluation the device passed all visual and functional testing.The device remained on throughout the duration of testing.The device was confirmed to be functioning as designed.E1.Initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (b)(6).Health effect impact code: no adverse event; no patient impact.

• Brand Name: EMMA
• 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: 23931627
• Report Number: 3019388613-2025-00184
• Device Sequence Number: 20236336
• Product Code: CCK
• UDI-Device Identifier: 07350046131033
• UDI-Public: (01)07350046131033(11)241030
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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: 06/10/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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