MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY LNCS NEO ADH SENSOR; OXIMETER

Model Number	2329
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Per medwatch (b)(4): "exposed wire was noted on the new, fresh out of package pulse oximeter.Replaced with another new pulse ox.Massimo reference number (b)(4) from packaging".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
The customer reported that the sensor is not available to return for masimo to perform an investigation.The sensor has not been returned to masimo to allow an analysis to be performed.If the sensor 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: LNCS NEO ADH SENSOR
• 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 ; 9492977167
• MDR Report Key: 25647475
• Report Number: 3019388613-2026-00349
• Device Sequence Number: 14919343
• Product Code: DQA
• UDI-Device Identifier: 10843997000922
• UDI-Public: (01)10843997000922(17)281001(10)25K1K
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2026

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: 2329
• Device Catalogue Number: 2329
• Device Lot Number: 25K1K
• 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: 06/03/2026
• Initial Report FDA Received Date: 06/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2025
• 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 Age: 21 DA
• Patient Sex: Male