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

Model Number 3150

Device Problem Battery Problem (2885)

Patient Problems Rash (2033); Superficial (First Degree) Burn (2685); Skin Inflammation/ Irritation (4545)

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

An incident was reported from fda medwatch program (ref report number: mw5105658) on 25jan2022 and sent out a brief incident description as below: patient was issued a nox medical, noxt3 home sleep test unit for diagnostic testing of sleep apnea.A component of the home sleep device is a pulse ox that is worn on the wrist throughout the night.The patient wore the home sleep test unit as directed by manufacturer instructions.When he took off the pulse ox from his left wrist the next morning, he noted a wound on the part of the skin that was covered by the pulse ox unit itself.There was a definitive area of skin irritation with white residue on the outlying area of skin.The wound appeared to be a possible skin burn related to the battery in the pulse ox unit.The patient was seen at a local ed department, and the physician noted the wound to be a rash.Following the event, the unit was assessed by the sleep technician.The batteries in the pulse ox unit were noted to have erosion with battery acid leakage both inside and outside the battery cavity.The device had new batteries placed just prior to issuing to the patient on (8)(6) 2021.The device was removed from circulation following the incident.Biomed assessed the unit for damage.The unit was sent to the manufacturer.After receiving the notification from the fda on 25jan2022, we communicated with nox regarding the incident.Nox confirmed that they received a notification on this incident on 28jan2022, which is a close date and aligns with the medwatch report event description and nox incident description.Therefore, there is a strong indication the incident received by nox is the same incident to the medwatch notification to nonin.Nox will be sending the nonin wrist ox2 ble serial number:(b)(4) involved in the incident to further investigate.Based on the information available and photos, nonin clinical reviewer determined that injury is consistent with skin irritation/1st-degree burn injury due to battery leakage and heat.Additionally, wound appearance strongly suggests a minor skin injury that can be treated with over-the-counter interventions/standard wound care.

Manufacturer Narrative

Regarding patient information, nothing further has been disclosed to nonin.Preexisting medical conditions could not be determined.The subject nonin device were returned to nonin for evaluation and testing.The unit is returned without batteries, door, and sensor.Test team inserted new set of batteries, sensor, and door to perform necessary testing.Visual inspection of the model 3150 shows evidence of white residues and corrosion at one end of the battery contacts.According to the event description, there is a white residue on the outlying area of the skin that indicates potential chemical venting from batteries.A literature search suggests this is most likely potassium hydroxide( white residue) emitted from an alkaline battery.The most common causes of battery leakage include: defective battery; battery installed backward; mismatch of batteries (charge level); batteries entirely flat (no charge).The nonin device showed no evidence of excessive heat.The device was thoroughly tested with new batteries and found to be fully functional, with no evidence of heat or electrical leakage.No battery failure/leakage was observed.Based on nonin's investigation of the returned device (vvtr12122) and the event description it is concluded that this incident is most likely a chemical burn from a venting battery (off the shelf battery not a nonin product).Nonin model 3150 wrist oximeter met all performance criteria.Did not confirm any temperature related changes or issues.

Event Description

An incident was reported from fda medwatch program (ref report number: mw5105658) on 25jan2022 and sent out a brief incident description as below: patient was issued a nox medical, noxt3 home sleep test unit for diagnostic testing of sleep apnea.A component of the home sleep device is a pulse ox that is worn on the wrist throughout the night.The patient wore the home sleep test unit as directed by manufacturer instructions.When he took off the pulse ox from his left wrist the next morning, he noted a wound on the part of the skin that was covered by the pulse ox unit itself.There was a definitive area of skin irritation with white residue on the outlying area of skin.The wound appeared to be a possible skin burn related to the battery in the pulse ox unit.The patient was seen at a local ed department, and the physician noted the wound to be a rash.Following the event, the unit was assessed by the sleep technician.The batteries in the pulse ox unit were noted to have erosion with battery acid leakage both inside and outside the battery cavity.The device had new batteries placed just prior to issuing to the patient on (b)(6) 2021.The device was removed from circulation following the incident.Biomed assessed the unit for damage.The unit was sent to the manufacturer.After receiving the notification from the fda on 25jan2022, we communicated with nox regarding the incident.Nox confirmed that they received a notification on this incident on (b)(6) 2022, which is a close date and aligns with the medwatch report event description and nox incident description.Therefore, there is a strong indication the incident received by nox is the same incident to the medwatch notification to nonin.Nox will be sending the nonin wrist ox2 ble serial number: b)(4) involved in the incident to further investigate.Based on the information available and photos, nonin clinical reviewer determined that injury is consistent with skin irritation/1st-degree burn injury due to battery leakage and heat.Additionally, wound appearance strongly suggests a minor skin injury that can be treated with over-the-counter interventions/standard wound care.

• Brand Name: WRISTOX2 PULSE OXIMETER BLE
• Type of Device: WRIST-WORN PULSE OXIMETER
• Manufacturer (Section D): NONIN MEDICAL, INC.; 13700 1st ave n; plymouth MN 55441
• Manufacturer Contact: brent geiger ; 13700 1st ave. n,; plymouth, MN 55441 ; 7635772670
• MDR Report Key: 13549600
• MDR Text Key: 296378932
• Report Number: 2183646-2022-00001
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2022
• 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: 113410-001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2019
• 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
• Treatment: NOX T3 SYSTEM; NOX T3 SYSTEM
• Patient Sex: Male