MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY NOMOLINE; OXIMETER

Model Number	4410
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.When co2 gas mixture was applied, the isa module measured outside the accuracy specification.After gas span calibration zeroing was performed and a co2 gas mixture was applied, the isa module measured within the accuracy specification.Incorrect gas span calibration zeroing resulted in measurements outside accuracy specification.S.
Event or Problem Description
The customer reported "bad results / reading." no patient impact or consequences were reported.

• Brand Name: NOMOLINE
• 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: 16078155
• Report Number: 3019388613-2022-00279
• Device Sequence Number: 17711087
• Product Code: CCK
• UDI-Device Identifier: 00843997014755
• UDI-Public: 00843997014755
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K063167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2022

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: 4410
• Device Catalogue Number: 4410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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