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

Model Number	3639
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: device evaluation is anticipated.When the device is evaluated 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 the emma was "consistently getting a low reading" as the measurements were "usually 5-8 under even after performing zeroing." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned emma was evaluated.The module was able to obtain measurements with all enabled parameters and all alarm conditions were audible and visual.When 5.00% co2 gas mixture was applied with atmospheric pressure of 762 mmhg, the emma measured at 43 mmhg co2.This reading was outside the accuracy specification of 36 mmhg to 41 mmhg.However, when zeroing of the device was performed, the emma measured 36 mmhg which is within specification.As such, the measurement issue was determined to a result of incorrect zeroing of the emma.
Event or Problem Description
The customer reported the emma was "consistently getting a low reading" as the measurements were "usually 5-8 under even after performing zeroing." 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24373918
• Report Number: 3019388613-2026-00048
• Device Sequence Number: 5583740
• Product Code: CCK
• UDI-Device Identifier: 07350046131033
• UDI-Public: (01)07350046131033(11)161101
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K201590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2026

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: 01/22/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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