MAUDE Adverse Event Report: NONIN MEDICAL, INC. NONIN 8004CB; OXIMETER, TISSUE SATURATION

Model Number 8004CB

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

Patient Problem Injury (2348)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

Device returned to nonin medical on 09oct2019 and is being evaluated.Nonin has been in direct communication with (b)(6) clinic (reporting site) since the initial report in june 2019.Sensors are being evaluated for correct functionality.Additionally nonin reviewed labeling which states:"inspect the sensor application site(s) 15 minutes after sensor application and at least every 2 to 4 hours to ensure correct sensor alignment and skin integrity.Patient sensitivity to the sensor may vary due to medical status or skin condition".

Event Description

This report is submitted by nonin medical inc to provide additional information to the initial report of mayo clinic ((b)(4)).Health care facility reported injury to patient.Despite repeated requests for device return, device arrived to nonin medical 09 oct 2019 for evaluation.At this time, it has not been determined whether device functionality was compromised at time of use.Device returned to nonin medical on 09oct2019 and is being evaluated.Nonin has been in direct communication with (b)(6) (reporting site) since the initial report in june 2019.Sensors are being evaluated for correct functionality.Additionally nonin reviewed labeling which states: "inspect the sensor application site(s) 15 minutes after sensor application and at least every 2 to 4 hours to ensure correct sensor alignment and skin integrity.Patient sensitivity to the sensor may vary due to medical status or skin condition".

• Brand Name: NONIN 8004CB
• Type of Device: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): NONIN MEDICAL, INC.; 13700 1st ave., north; plymouth MN 55441 5443
• Manufacturer (Section G): NONIN MEDICAL, INC.; 13700 1st ave., north; plymouth MN 55441 5443
• Manufacturer Contact: walter holbein ; 13700 1st ave. north; plymouth, MN 55441-5443 ; 7635775504
• MDR Report Key: 9276238
• MDR Text Key: 165012072
• Report Number: 2183646-2019-00001
• Device Sequence Number: 1
• Product Code: MUD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8004CB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other