NONIN WRISTOX2 PULSE OXIMETER 3150 110204-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-02-14 for NONIN WRISTOX2 PULSE OXIMETER 3150 110204-001 manufactured by Nonin Medical, Inc..

Event Text Entries

[180340811] 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.
Patient Sequence No: 1, Text Type: N, H10


[180340812] The patient described going to bed around 10-11 pm, and was awaken by a burning sensation around 3-4 am. He then took off the device and placed ice cubes on the burn site, his right wrist.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2183646-2020-00002
MDR Report Key9713232
Report SourceDISTRIBUTOR
Date Received2020-02-14
Date of Report2020-02-14
Date of Event2020-01-30
Date Mfgr Received2020-02-07
Date Added to Maude2020-02-14
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. BRENT GEIGER
Manufacturer Street13700 1ST AVE. N
Manufacturer CityPLYMOUTH, MN
Manufacturer CountryUS
Manufacturer Phone5772670
Manufacturer G1NONIN MEDICAL, INC.
Manufacturer Street13700 1ST AVE. N
Manufacturer CityPLYMOUTH, MN
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNONIN WRISTOX2 PULSE OXIMETER
Generic NameWRIST-WORN PULSE OXIMETER
Product CodeDQA
Date Received2020-02-14
Model Number3150
Catalog Number110204-001
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNONIN MEDICAL, INC.
Manufacturer Address13700 1ST AVE. N PLYMOUTH, MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-02-14

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