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

Model Number MODEL 3150

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

Patient Problems Burn(s) (1757); Burning Sensation (2146)

Event Date 01/30/2020

Event Type  Injury  

Manufacturer Narrative

Nox medical is a repackager of the nonin 3150 pulse oximeter, that is included in the nox t3 system.The legal manufacturer of the finished device is nonin medical inc.That has been notified of the reported event.The suspected device will be sent directly from nox medical llc (the importer and distributor) to nonin medical (the finished device legal manufacturer) for further evaluation.Nox medical has evaluated the information related to this reported event and came to the conclusion that the incident is not related to the repackaging of the nonin 3150 pulse oximeter performed by nox medical.Any further reports will come from nonin medical inc.The finished device legal manufacturer.

Event Description

Mr.(b)(6) called and described going to bed 10-11 pm, he was awakened by stinging sensation around 3-4 am.He then took the device off and placed ice cubes on his burn site (right hand/wrist area).Burn injury on wrist area.

• Brand Name: NONIN WRISTOX2 PULSE OXIMETER
• Type of Device: WRIST-WORN PULSE OXIMETER
• Manufacturer (Section D): NONIN MEDICAL INC.; 13700 1st ave, north; plymouth MN 55441
• Manufacturer (Section G): NOX MEDICAL; katrínartúni 2; reykjavík, 105 ; IC 105
• Manufacturer Contact: kolbrún ottosdóttir ; katrínartúni 2; reykjavík, 105 ; IC 105
• MDR Report Key: 9680513
• MDR Text Key: 178545548
• Report Number: 3007389703-2020-00002
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• PMA/PMN Number: K102350
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MODEL 3150
• Device Catalogue Number: 110204-001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/03/2020
• Was Device Evaluated by Manufacturer?: No
• 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