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

Catalog Number	LP-PBXMASI1S2P
Medical Device Problem Codes	Defective Device (2588); Battery Problem (2885); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As a biomed technician i found that approximately 30% of the batteries in the masimo radical spo2 device are swelling with gasses and posing potential fire hazard.Spoke to masimo tech support and they are aware of the issue but have not enacted a recall voluntarily.I would think that due to the volatility of lithium ion batteries that are compromised this issue should receive more attention.Part number- lp-pbxmasi1s2p.

• Brand Name: RADICAL-7
• Common Device Name: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION
• MDR Report Key: 16919551
• Report Number: MW5117485
• Device Sequence Number: 6328829
• Product Code: DQA
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 05/09/2023

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
• Device Catalogue Number: LP-PBXMASI1S2P
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/11/2023
• Patient Sequence Number: 1
• Patient Sex: Male