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

Model Number 4585

Device Problems Break (1069); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/29/2022

Event Type  Injury  

Event Description

Battery compartment of wristband forcefully separated/exploded 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 28232
• MDR Report Key: 14843570
• MDR Text Key: 294941830
• Report Number: MW5110543
• 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: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4585
• Device Lot Number: A20EJ18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male