MAUDE Adverse Event Report: MASIMO CORPORATION MASIMOSET LNCS ADTX SPO2 ADULT PULSE OXIMETER ADHESIVE SENSOR

Model Number	1859
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Masimo lncs adtx spo2: adult pulse oximeter adhesive sensor.Lot # 24am1.Upon changing o2 probe for patient, applied new probe to patient's finger, attached correctly to bedside monitor cable, spo2 not reading, and notice on ge bedside monitor "faulty probe".

• Brand Name: MASIMOSET LNCS ADTX SPO2 ADULT PULSE OXIMETER ADHESIVE SENSOR
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 20223753
• Report Number: 20223753
• Device Sequence Number: 15389856
• Product Code: DQA
• UDI-Device Identifier: 00843997000291
• UDI-Public: (01)00843997000291
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/09/2024
• Report Date (Section F): 05/09/2024

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: 1859
• Device Catalogue Number: 1859
• Device Lot Number: 24AM1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2024
• 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: 82 YR
• Patient Sex: Male
• Date Report Sent to FDA: 05/09/2024