MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEO CS-3; OXIMETER

Model Number	4478
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Masimo has reached out to the customer and the onsite masimo representatives to request the return of the device.The product has not been returned to masimo headquarters 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, per the medwatch "while on transport and while getting ready to intubate patient, oxygen saturation probe went flatline and stopped reading.After intubating patient and getting settled, replaced oxygen saturation probe with a new one and started working again." there was no patient impact or consequence reported.

• Brand Name: RD SET NEO CS-3
• 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: sara ghoudjehbaklou ; 15750 alton pkwy; irvine, CA 92618 ; 9499191475
• MDR Report Key: 19226521
• Report Number: 3019388613-2024-00055
• Device Sequence Number: 7658656
• Product Code: DQA
• UDI-Device Identifier: 10843997013267
• UDI-Public: 10843997013267
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2024

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 Expiration Date: 03/01/2026
• Device Model Number: 4478
• Device Catalogue Number: 4478
• Device Lot Number: 23CRA
• 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: 04/09/2024
• Initial Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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