MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY EMMA (MMHG) CAPNOGRAPH KIT; OXIMETER

Model Number	18265
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported the emma was inaccurate.No consequences or impact to patient were reported.
Additional Manufacturer Narrative
Additional manufacturing narrative: the returned device was evaluated.The optical detector lens was found to be recessed during visual inspection.During accuracy testing, the device provided a measurement outside the accuracy specification.Performed a zeroing of the device and the measured value remained the same with the gas mixture applied.A service history record review reveals that this unit was in the field for over three (3) years with no previous reported issues related to this reported event.
Event or Problem Description
The customer reported the emma was inaccurate.No consequences or impact to patient were reported.

• Brand Name: EMMA (MMHG) CAPNOGRAPH KIT
• Common Device Name: OXIMETER
• 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: matofa fautua ; 15750 alton pkwy; irvine, CA 92618 ; 9498223661
• MDR Report Key: 13122370
• Report Number: 3019388613-2021-00375
• Device Sequence Number: 4664904
• Product Code: CCK
• UDI-Device Identifier: 07350046131750
• UDI-Public: 07350046131750
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K063167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: 18265
• Device Catalogue Number: 3639
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/07/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 12/30/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2019
• 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