MAUDE Adverse Event Report: NONIN MEDICAL, INC. NONIN WRISTOX2 PULSE OXIMETER; WRIST-WORN PULSE OXIMETER

Model Number 3150

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Burn(s) (1757)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

Regarding patient information, nothing further has been disclosed to nonin.Preexisting medical conditions could not be determined.Actions taken after device was removed from patient could also not be determined.Nonin is waiting on the return of the device, and once received, will subject it to investigation and testing.

Event Description

Patient woke up around midnight feeling a burning sensation on her wrist, where the nonin wristox2 device was placed.Patient then removed the device and noticed that the battery door had slid down 1/4 of the way.A blister had been found later at the same location of the wristox2.

• Brand Name: NONIN WRISTOX2 PULSE OXIMETER
• Type of Device: WRIST-WORN PULSE OXIMETER
• Manufacturer (Section D): NONIN MEDICAL, INC.; 13700 1st ave. n; plymouth, mn
• Manufacturer (Section G): NONIN MEDICAL, INC.; 13700 1st ave. n; plymouth, mn
• Manufacturer Contact: brent geiger ; 13700 1st ave. n; plymouth, mn ; 5772670
• MDR Report Key: 9696064
• MDR Text Key: 180340591
• Report Number: 2183646-2020-00001
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 3150
• Device Catalogue Number: 110204-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other