MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO RADIUS PPG TETHERLESS PULSE OXIMETRY; OXIMETER

Model Number RADIUS PPG

Device Problem Material Separation (1562)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 07/27/2022

Event Type  Injury  

Event Description

Battery compartment on wrist device forcefully separated while in use on patient.Fda safety report id# (b)(4).

• Brand Name: MASIMO RADIUS PPG TETHERLESS PULSE OXIMETRY
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; irvine CA
• MDR Report Key: 15174520
• MDR Text Key: 297465542
• Report Number: MW5111290
• 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: 08/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RADIUS PPG
• Device Catalogue Number: 4585
• Device Lot Number: 22EWY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female