MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO PULSE OXIMETER PROBE

Model Number 1862

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 01/24/2022

Event Type  Injury  

Event Description

Patient received burn on his foot according to his father from an masimo pulse oximeter probe 1862 overheating.The sensor cable is browned from excessive heat.Pox unit itself does not appear to be damaged, but the disposable sensor is and from it the patient was burned.Dme was exchanged with another unit.Patient was not taken to the doctor or er.Fda safety report id # (b)(4).

• Brand Name: MASIMO PULSE OXIMETER PROBE
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; irvine CA 92618
• MDR Report Key: 13426213
• MDR Text Key: 284996342
• Report Number: MW5107160
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1862
• Device Catalogue Number: 1862
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 MO
• Patient Sex: Male