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.
[57382953]
(b)(4). (b)(4) 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
[57382954]
The customer reported that while their patient was wearing the t3 nonin 3150 pulse oximeter the patient reported a bump and burn on their left finger. The patient has not been seen by any medical professional about the burn to date. 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
| Report Number | 2021710-2016-04638 |
| MDR Report Key | 6028465 |
| Date Received | 2016-10-13 |
| Date of Report | 2016-09-20 |
| Date of Event | 2016-09-20 |
| Date Facility Aware | 2016-09-20 |
| Report Date | 2016-10-13 |
| Date Reported to FDA | 2016-10-13 |
| Date Reported to Mfgr | 2016-09-26 |
| Device Manufacturer Date | 2015-05-01 |
| Date Added to Maude | 2016-10-13 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOX T3, NOXTURNAL |
| Generic Name | VENTILATORY EFFORT RECORDER |
| Product Code | MNR |
| Date Received | 2016-10-13 |
| Model Number | T3 SLEEP MONITOR |
| Catalog Number | 22857-001 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | 14 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOX MEDICAL |
| Manufacturer Address | IMPRA KELDNAHOLTI IS112 REYKJAVIK IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-13 |