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

Model Number	18625
Medical Device Problem Code	Unexpected Shutdown (4019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacuring narrative: other, other text: the device has not been returned to the investigation facility to allow for an analysis to be performed. if the product is received for evaluation or new information is obtained, a follow up report will be submitted.H3 other text : product not returned.
Event or Problem Description
The customer reported the emma "shutdown by itself." there was no patient impact or consequence reported.

• Brand Name: EMMA CAPNOGRAPH
• 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: sara ghoudjehbaklou ; 15750 alton pkwy; irvine, CA 92618 ; 9499191475
• MDR Report Key: 19367298
• Report Number: 3019388613-2024-00068
• Device Sequence Number: 14399129
• Product Code: CCK
• UDI-Device Identifier: 07350046131033
• UDI-Public: 07350046131033
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K063167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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: 18625
• Device Catalogue Number: 3639
• Was Device Available for Evaluation?: No
• 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: 04/26/2024
• Initial Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2016
• 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