MAUDE Adverse Event Report: MASIMO CORPORATION SPO2 CABLE; OXIMETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2022

Event Type  Death  

Event Description

This letter is to inform you that on 16 february 2022, ge healthcare became aware of a patient death which involved another manufacturer's product (ge record# (b)(4)).A masi mo sp02 cable was identified as having been involved with a patient death on (b)(6)2022.Masimo has also been notified of the event.Incident details: based on the available information received from the hospital's biomedical technician, the reason for patient incident is not due to ge equipment but may be due to the masimo corp spo2 cable.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SPO2 CABLE
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION
• MDR Report Key: 17536905
• MDR Text Key: 321043706
• Report Number: MW5143788
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1