MAUDE Adverse Event Report: NONIN MEDICAL NONIN PULSE OXIMETRY SENSOR; OXIMETER

Model Number 6000CA

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Burn, Thermal (2530)

Event Date 04/18/2018

Event Type  malfunction  

Event Description

Undergoing home sleep study, pt reports a small burn on finger from oximetry sensor.

• Brand Name: NONIN PULSE OXIMETRY SENSOR
• Type of Device: OXIMETER
• Manufacturer (Section D): NONIN MEDICAL; plymouth MN 55441
• MDR Report Key: 7453894
• MDR Text Key: 106413615
• Report Number: MW5076666
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 6000CA
• 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 Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 68