MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET NEO/ADT PULSE OX SENSOR; OXIMETER

Model Number	4003
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Codes	Bradycardia (1751); Cyanosis (1798); Hypoxia (1918)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: the returned sensor was evaluated, during evaluation the sensor passed all visual and functional testing.The sensor was able to obtain spo2 and pulse rate values throughout the entire 16 hours of testing.The sensor was confirmed to be functioning as designed.E1: initial reporter zip code exceeded the maximum allowable characters, zip code is as follows: (b)(6).
Event or Problem Description
The customer reported that "the masimo sensor wasn't working, and it could have been critical".The customer noticed the masimo sensor wasn't working, even though everything was connected.It had a flat line on the screen for the oxygen saturation reading and some symbols.The patient started experiencing a very rapid bradycardia; it went from around 130 bpm to 100 bpm to 39 bpm, and then no numbers were displayed, only "asyst" and very large gaps between the qrs complexes; she was hypotonic, acrocyanotic, very pale.The customer noted they will never know how low this baby's oxygen saturation dropped, with a brady score of 39 and maybe even lower.There was a patient impact reported.

• Brand Name: RD SET NEO/ADT PULSE OX 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24751105
• Report Number: 3019388613-2026-00119
• Device Sequence Number: 10145071
• Product Code: DQA
• UDI-Device Identifier: 10843997009598
• UDI-Public: (01)10843997009598(17)290101(10)26A95
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2026

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: 4003
• Device Lot Number: 26A95
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2026
• 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: 03/06/2026
• Initial Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2026
• 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