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 Problems Edema (1820); Injury (2348)

Event Date 03/26/2019

Event Type  Injury  

Manufacturer Narrative

The sensor was used with a compatible nonin sensmart oximetry system.However, 2 of the 4 sensors were invos (manufactured by medtronic).Nonin has not conducted testing for compatibility of the sensmart system with the invos device.It has not been determined if these devices (invos and 8004cb) can be used concurrently.The labeling of senssmart indicates that the system should only be used with compatible nonin sensors.Device was evaluated at advocate children's hospital by (b)(4) personnel on 16 apr 2019.On-site temperature measurements did not indicate nor raise a suspicion of a potential for a heat related burn.Functional testing showed failure of sensor - evaluators determined that this may be a result of the storage method used while awaiting testing and evaluation.Note: data obtained during the or procedure provided evidence that the sensor was operational and providing rso2 readings during it.

Event Description

Sensmart system was being evaluated by advocate children's hospital for use in its facility approximately one month prior to the incident.The patient was monitored from (b)(6) 2019 using four (4) sensors - two on the forehead and two on the back.The sensors were placed on intact skin.The sensor(s) had been in place for 24 hours.During this time, two small pinpoint superficial wounds developed on the forehead.Each approximately 0.2cm x 0.2cm.Note: prior to removal of the sensor that is the subject of this report, it was noted that the patient had generalized edema.Patient injury was treated by with silvadene and covered with mepilex.

• 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 Contact: walter holbein ; 13700 1st ave. north; plymouth, MN 55441-5443 ; 7635775504
• MDR Report Key: 9278871
• MDR Text Key: 179518377
• Report Number: 2183646-2019-00002
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8004CB
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 DA