MAUDE Adverse Event Report: MASIMO - 15750 ALTON PKWY SET LNCS ADTX ADHESIVE SENSOR; OXIMETER

Model Number	1859
Medical Device Problem Codes	Unraveled Material (1664); Structural Problem (2506); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	04/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text: sensor not returned.
Event or Problem Description
Per medwatch report mw5187461, "while patient using adult pulse oximeter adhesive sensor on finger and urinal - wires exposed still protected with covering but patient believes he urinated on wires and received a lightening bolt sensation up his arm.".

• Brand Name: SET LNCS ADTX ADHESIVE 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: 25345696
• Report Number: 3019388613-2026-00279
• Device Sequence Number: 18688012
• Product Code: DQA
• UDI-Device Identifier: 10843997000298
• UDI-Public: (01)10843997000298(17)281101(10)25MV4
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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: Lay User/Patient
• Device Model Number: 1859
• Device Catalogue Number: 1859
• Device Lot Number: 25MV4
• 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: 05/11/2026
• Initial Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2025
• 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: 71 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White