MAUDE Adverse Event Report: Masimo - 15750 Alton Pkwy RD SET; Oximeter

Model Number	4473
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a baby undergoing phototherapy, with the spo2 sensor shielded from light by a strip.The sensor had been reading accurately for the past two days.The baby has had stable vital signs since birth.Suddenly, the spo2 drops to 30%.After removing the baby from phototherapy and waking him up, he showed no clinical signs of desaturation.After replacing the oxygen saturation sensor, the spo2 level returned to 96%.There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: 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.

• Brand Name: RD SET
• Common Device Name: Oximeter
• Manufacturer (Section D): Masimo - 15750 Alton Pkwy; 15750 alton pkwy; irvine CA 92618
• Manufacturer (Section G): Masimo - Medical Technologies (Malaysia) Sdn Bhd; lot 198512, (plo 547-b) jalan keluli 11, zon 12a; kawasan perindustrian pasir gudang 81700 ; MY 81700
• Manufacturer Contact: lusine boyadzhyan ; 15750 alton pkwy; irvine, CA 92618 ; +1(949)297-7167
• MDR Report Key: 50910647
• Report Number: 3019388613-2026-00699
• Device Sequence Number: 5804110
• Product Code: DQA
• UDI-Device Identifier: 10843997013229
• UDI-Public: (01)10843997013229(17)280201(10)E25BU5
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: 4473
• Device Lot Number: E25BU5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2025
• 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: Male