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

Model Number	18266
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the device showing low reading on 5% co2.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: attempts have been made to obtain the product.The product has not been returned to masimo to allow an analysis to be performed.If the product is returned for evaluation or new information is obtained, a follow up report will be submitted.
Additional Manufacturer Narrative
Additional manufacturing narrative: other, other text: the returned device was evaluated.Visual inspection found the detector lens was tilted.The device was able to power on and off using battery power and was able to obtain measurements with all of the enabled parameters.When a co2 gas mixture was applied, the measured values were outside the accuracy specification.After performing zeroing of the device, the measured values remained outside of the accuracy specification due to the titled detector lens.Initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).
Event or Problem Description
The customer reported the device showing low reading on 5% co2.No consequences or impact to patient were reported.

• Brand Name: EMMA CAPNOGRAPH, KPA
• 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: 16443861
• Report Number: 3019388613-2023-00047
• Device Sequence Number: 5599610
• Product Code: CCK
• UDI-Device Identifier: 07350046131040
• UDI-Public: 07350046131040
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 02/03/2023

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: 18266
• Device Catalogue Number: 3678
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2019
• 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