NOX T3, NOXTURNAL T3 SLEEP MONITOR 22857-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-13 for NOX T3, NOXTURNAL T3 SLEEP MONITOR 22857-001 manufactured by Nox Medical.

Event Text Entries

[57398005] (b)(4). Carefusion is the importer of record for this device. The legal manufacturer (nox medical) has been notified of the reported event. Any further reports will come from the legal manufacturer.
Patient Sequence No: 1, Text Type: N, H10


[57398006] The customer reported that while their patient was wearing the t3 nonin 3150 pulse oximeter the patient reported a bump and burn on their finger. The patient was seen by a nurse practioner and was given topical cream to address burn. The customer believes that their patient's issue was due to the red light in the finger probe. The device was returned to the customer by the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2016-04639
MDR Report Key6028455
Date Received2016-10-13
Date of Report2016-09-20
Date of Event2016-09-20
Date Facility Aware2016-09-20
Report Date2016-10-13
Date Reported to FDA2016-10-13
Date Reported to Mfgr2016-09-26
Device Manufacturer Date2015-05-01
Date Added to Maude2016-10-13
Event Key0
Report Source CodeDistributor report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRESPIRATORY THERAPIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNOX T3, NOXTURNAL
Generic NameVENTILATORY EFFORT RECORDER
Product CodeMNR
Date Received2016-10-13
Model NumberT3 SLEEP MONITOR
Catalog Number22857-001
OperatorLAY USER/PATIENT
Device AvailabilityY
Device Age14 MO
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerNOX MEDICAL
Manufacturer AddressIMPRA KELDNAHOLTI IS112 REYKJAVIK IC


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-10-13

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