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

Model Number	4050
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned sensor was evaluated.The sensor passed visual inspection and continuity testing.The sensor was able to obtain spo2 readings continuously without any intermittent readings being observed.The sensor was determined to be functioning as designed.Of the 13 returned concomitant cables: - 9 cables were found to be physically damaged.This resulted in an error message being displayed and the lab monitor providing an audible and visual alarm for 7 of the 9 cables.Continuity and functionality testing could not be conducted on the remaining 2 cables as the damage prevented the cables from being able to connect to the lab tester/module.- 1 cable was found to have chemical residue on and around the pogo pins.The residue did not impact the functionality of the cable - 3 cables passed visual inspection and continuity testing.The cables were determined to be functioning as designed.Health effect impact code: no adverse event, no patient impact.Submission was delayed due to masimo identifying unauthorized activity on the company¿s on-premises network.Upon detection, masimo activated its incident response protocol and incident containment measures including proactively isolating impacted systems, which resulted an inability to access our electronic complaint files preventing us from submitting mdrs on time.
Event or Problem Description
The customer reported experiencing "dropouts and readings coming in and out" with the cables and sensor.There was no patient impact or consequence reported.

• Brand Name: RD SET DCI SPO2 ADULT REUSE FINGER CLIP
• 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: 22177514
• Report Number: 3019388613-2025-00042
• Device Sequence Number: 21134530
• Product Code: DQA
• UDI-Device Identifier: 00843997009843
• UDI-Public: (01)00843997009843(11)230710(10)23F4W
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2025

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: 23F4W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• 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: 04/08/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: R25-12 LOTS 23NTA 23N34 23ECX 23JGL
• Patient Sex: Unknown