MAUDE Adverse Event Report: MASIMO CORPORATION RADICAL-7®; OXIMETER

Model Number 9500

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2022

Event Type  malfunction  

Event Description

When the staff went to take the spo2 of the patient they got a mx board failure error.Manufacturer response for oximeter, radical-7® (per site reporter).They replaced the device, but after a lot of investigation they believe that this occurred because there may have been a short in the pins of the patient cable.It may have been recently cleaned and not fully dried.They have since educated the staff on how to properly clean the patient cables.

• Brand Name: RADICAL-7®
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 16597533
• MDR Text Key: 311847614
• Report Number: 16597533
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/13/2023,11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 9500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2023
• Device Age: 10 MO
• Date Report to Manufacturer: 03/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1