MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY RD SET DCI SPO2 ADULT REUSABLE FINGER CLIP SENSOR; OXIMETER

Model Number	4050
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the "saturation of peripheral oxygen (spo2) probes are on cardiac monitoring defibrillators and have been exhibiting intermittent faults leading to no or false and inaccurate readings with high heart rate"; "intermittent pulse oximeter photoplethysmograph, and spo2 readings on the cardiac monitoring defibrillator".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.The lot number provided is invalid, no masimo sensors manufactured have lot# "e248mt".Therefore, no manufacturing date could be derived for the udi entry.E1: initial reporter phone number exceeded maximum allowable digits, phone number is as follows: (b)(6).E1: initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (b)(6).This is report 5 of 17 for patient #5.H3 other text: product not returned.

• Brand Name: RD SET DCI SPO2 ADULT REUSABLE FINGER CLIP 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: 24127389
• Report Number: 3019388613-2026-00013
• Device Sequence Number: 12120194
• Product Code: DQA
• UDI-Device Identifier: 00843997009843
• UDI-Public: (01)00843997009843(10)E248MT
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

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: 4050
• Device Lot Number: E248MT
• 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: 12/22/2025
• Initial Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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