MAUDE Adverse Event Report: MASIMO CORPORATION RADICAL 7; OXIMETER

Model Number VKF-RAD7A

Device Problems Image Display Error/Artifact (1304); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

Massimo radical 7 portable pulse ox units continuously malfunctioning.When turned on, screen continues to jump rendering device useless.Company has been notified on multiple occasions and has been replacing devices with new ones.Problem continues to occur frequently enough that replacement is not fast enough to keep up with malfunctioning devices.Company states willing but unable to replace entire product line due to contract.4 devices: serial #'s: (b)(4).Manufacturer response for portable pulse oximeter, radical 7 (per site reporter).All devices replaced with new devices.New devices tagged to track if new devices are also malfunctioning.

• Brand Name: RADICAL 7
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; 52 discovery; irvine CA 92618
• MDR Report Key: 12810572
• MDR Text Key: 280749863
• Report Number: 12810572
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2021

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 Operator: Health Professional
• Device Model Number: VKF-RAD7A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2021
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White