MAUDE Adverse Event Report: MASIMO CORPORATION MASIMO RD SET ADT ADULT PULSE OXIMETER SENSOR

Model Number 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Swelling (2091); No Code Available (3191)

Event Date 09/21/2020

Event Type  Injury  

Event Description

On patient discharge, day 4, an o2 sensor was found to have caused a blister.Patient was discharged.Then returned for an unrelated procedure and found blackening of tip of finger.Referred to plastics for evaluation.I do not have a picture of the product but a picture of the patient's finger showing the injury.Fda safety report id# (b)(4).

• Brand Name: MASIMO RD SET ADT ADULT PULSE OXIMETER SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION ; irvine CA 92618
• MDR Report Key: 10755845
• MDR Text Key: 213929264
• Report Number: MW5097548
• Device Sequence Number: 1
• Product Code: DQA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/27/2020

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: 4000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention