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

Model Number	2329
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
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 h3 other text : product not returned.
Event or Problem Description
The customer reported that "wires in our pulse ox sensor have become exposed when attempting to change out the brown fabric sticker (replacement tape).New pulse ox sensor noted to have exposed wires when removing from package".There was no patient impact or consequence reported.
Additional Manufacturer Narrative
Other, other text: the returned sensor was evaluated.The sensor was returned with missing adhesive head-tape.The internal wires were exposed as the tape was physically removed from the sensor cable.The sensor passed continuity testing, however the sensor was unable to be functionally tested due to the missing tape assembly.The customer's reported issue could not be replicated in testing.Health effect impact code: no adverse event; no patient impact.
Event or Problem Description
The customer reported that "wires in our pulse ox sensor have become exposed when attempting to change out the brown fabric sticker (replacement tape).New pulse ox sensor noted to have exposed wires when removing from package".There was no patient impact or consequence reported.

• Brand Name: SET LNCS NEO/ADT 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: rishi jain ; 15750 alton pkwy; irvine, CA 92618
• MDR Report Key: 24736659
• Report Number: 3019388613-2026-00111
• Device Sequence Number: 10191838
• Product Code: DQA
• UDI-Device Identifier: 10843997000922
• UDI-Public: (01)10843997000922(17)280801(10)25HZ4
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 25HZ4
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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 Age: 16 YR
• Patient Sex: Female