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

Model Number MODEL 3150

Device Problems Structural Problem (2506); Unintended Movement (3026)

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

Event Date 01/17/2020

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 (b)(4) (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

Patient being burned on the wrist.The patient described around midnight waking up feeling a burning sensation on her wrist where the nonin wrist ox was worn.She took the wrist ox device off and noticed the battery door had slid 1/4 of the way open.She took the battery out, then placed it back in and slid the door closed and resumed the study.(b)(6) describes the patient wrist area with a blister, that would eventually open.

• Brand Name: NONIN WRISTOX2 PULSE OXIMETER
• Type of Device: WRIST-WORN PULSE OXIMETER, PRODUCT CODE
• Manufacturer (Section D): NONIN MEDICAL INC.; 13700 1st ave, north; plymouth MN 55441
• Manufacturer (Section G): NOX MEDICAL; katrinartuni 2; reykjavik, 105 ; IC 105
• Manufacturer Contact: kolbrún ottosdóttir ; katrinartuni 2; reykjavik, 105 ; IC 105
• MDR Report Key: 9647597
• MDR Text Key: 180900108
• Report Number: 3007389703-2020-00001
• 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: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 01/30/2020
• Was Device Evaluated by Manufacturer?: No
• 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