MAUDE Adverse Event Report: MASIMO CORPORATION PULSE OXIMETRY SENSOR; OXIMETER

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hyperventilation (1910); High Oxygen Saturation (2478)

Event Date 11/22/2020

Event Type  malfunction  

Event Description

Patient appeared to be desaturating to the 70's per massimo forehead pulse oximetry sensor.Interventions immediately began to improve oxygenation.No improvement per pulse ox.Pulse ox was lined up with pupil, headband properly placed, full pleth and carat with no indication of inaccurate reading per massimo guidelines.New senor placed in the same position as the old sensor and resulting in a reading of 100% spo2.Arterial blood gas sent showing hyperventilation and hyper oxygenation as a result of interventions based on faulty original pulse ox reading.Fda safety report id # (b)(4).

• Brand Name: PULSE OXIMETRY SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): MASIMO CORPORATION; irvine CA 92618
• MDR Report Key: 10919103
• MDR Text Key: 218976980
• Report Number: MW5098128
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Age: 61 YR