MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RNBW DCIDC3 ADULT REUSABLE SPO2 SENSOR; OXIMETER

Model Number	2201
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Masimo has reached out to the customer to request the return of the device.The device has not been returned to masimo to allow an analysis to be performed.If the device is returned for evaluation or new information is obtained, a follow up report will be submitted.Health effect impact code: no adverse event; no patient impact.E1.Initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).
Event or Problem Description
The customer reported that the sensor fails randomly.The sensor, "randomly stops reading; no error messages or alarms were displayed on the host monitor".There was no patient impact or consequence reported.

• Brand Name: RNBW DCIDC3 ADULT REUSABLE SPO2 SENSOR
• 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: tahereh sedighi ; 15750 alton pkwy; irvine, CA 92618 ; 9492977862
• MDR Report Key: 23012346
• Report Number: 3019388613-2025-00100
• Device Sequence Number: 13196939
• Product Code: DQA
• UDI-Device Identifier: 00843997001663
• UDI-Public: (01)00843997001663(11)221118(10)22MXK
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K080238
• 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
• Report Date (Section B): 08/14/2025

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: 2201
• Device Catalogue Number: 2201
• Device Lot Number: 22MXK
• 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: 08/14/2025
• Initial Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2022
• 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