MAUDE Adverse Event Report: MASIMO - INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C EMMA CAPNOGRAPHY; 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	04/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Field e.1.Phone #: (b)(6).
Event or Problem Description
The customer reported that the "power turns off while using it (even after changing the battery), poor airway adapter recognition".
Additional Manufacturer Narrative
Other, other text: the returned emma was evaluated.The device passed visual and functionality testing.The device was able to remain on and no product performances issues identified.The device was determined to be functioning as designed.E1: initial reporter phone number exceeded allowable field length, initial reporter phone number is as follows: (b)(6).Health effect impact code: no adverse event, no patient impact.
Event or Problem Description
The customer reported that the "power turns off while using it (even after changing the battery), poor airway adapter recognition." no patient impact or consequences were reported.

• Brand Name: EMMA CAPNOGRAPHY
• Common Device Name: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): MASIMO - INDUSTRIAL VALLERA DE MEXICALI, S.A. DE C; calzada del oro #2001 int.5&6; parkue ind. palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer (Section G): MASIMO - MEXICALI; industrial vallera de mexicali calzada del oro, no.2001; parkue ind. palaco; mexicali, baja california 21600 ; MX 21600
• Manufacturer Contact: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 22073971
• Report Number: 3019388613-2025-01001
• Device Sequence Number: 9337823
• Product Code: CCK
• UDI-Device Identifier: 00843997017985
• UDI-Public: (01)00843997017985(11)231101
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K201590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2025

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
• 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: 04/21/2025
• Supplement Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• 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