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	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: masimo has reached out to the customer to request the return of the cables and sensors.The product has not been returned to masimo to allow an analysis to be performed.If the product 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.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 the cables and sensors "dropped out." there was no patient impact or consequence reported.
Event or Problem Description
The customer reported the cables and sensors "dropped out." there was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the customers returned 13 sensors and 12 cables for evaluation.For 5 of the 13 sensors, an open in the cable on the detector circuit was observed at the bend relief area of the rd15 connector.An error message was triggered on the lab monitor during functionality testing.For 1 of the 13 sensors, a cut on the outer jacket along the length of the cable was observed.The sensors was able to obtain spo2 and pulse rate measurements during functionality testing.No product performance issues related to measurement were observed.The remaining 7 sensors passed visual inspection and functionality testing.The sensors were determined to be functioning as designed.For 2 of the12 cables, a cut on the outer jacket along the length of the cable was observed.The cables were able to obtain spo2 and pulse rate measurements during functionality testing.No product performance issues related to measurement were observed.For 1 of the 12 cables, a loose outer jacket at the rd15 connector was observed.The cable was able to obtain spo2 and pulse rate measurements during functionality testing.No product performance issues related to measurement were observed.The remaining 9 cables passed visual inspection and functionality testing.The cables were determined to be functioning as designed.E1: initial reporter zip code exceeded the maximum allowable characters; zip code is as follows: (b)(6).

• 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 ; 52 discovery; irvine, CA 92618 ; 9492977862
• MDR Report Key: 22172532
• Report Number: 3019388613-2025-00034
• Device Sequence Number: 7789306
• Product Code: DQA
• UDI-Device Identifier: 00843997009843
• UDI-Public: (01)00843997009843(11)240312(10)E24BGY
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K180046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2025

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: E24BGY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/10/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2024
• 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 CABLES-LOTS 24B14 AND 24F20
• Patient Sex: Unknown