MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-23 for NOX T3, NOXTURNAL T3 SLEEP MONITOR 22857-001 manufactured by Nox Medical.
[48292293]
Carefusion file identification: (b)(4). Importer report number: 2021710-2016-00003 (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
[48292294]
The customer reported that while troubleshooting a different issue with carefusion technical support the device became very hot, shutdown, and would not power on again. The customer reported that they had just changed the batteries in the device approximately 30 minutes prior to the occurrence of the reported incident. The customer stated that they could smell something that smelled like burnt plastic however the customer did not note any area on the device that appeared to be burned. The customer then stated that she removed the batteries and sat the device aside until it cooled down. There was no report of any patient involvement and no report of serious injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021710-2016-03954 |
| MDR Report Key | 5746831 |
| Date Received | 2016-06-23 |
| Date of Report | 2016-06-02 |
| Date of Event | 2016-06-02 |
| Date Facility Aware | 2016-06-02 |
| Report Date | 2016-06-23 |
| Date Reported to FDA | 2016-06-23 |
| Date Reported to Mfgr | 2016-06-06 |
| Date Mfgr Received | 2016-06-02 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2016-06-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 22745 SAVI RANCH PARKWAY |
| Manufacturer City | YORBA LINDA CA 92887 |
| Manufacturer Country | US |
| Manufacturer Postal | 92887 |
| Manufacturer Phone | 7149227830 |
| Manufacturer G1 | NOX MEDICAL |
| Manufacturer Street | IMPRA KELDNAHOLTI IS 112 |
| Manufacturer City | REYKJAVIK |
| Manufacturer Country | IC |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NOX T3, NOXTURNAL |
| Generic Name | VENTILATORY EFFORT RECORDER |
| Product Code | MNR |
| Date Received | 2016-06-23 |
| Returned To Mfg | 2016-06-23 |
| Model Number | T3 SLEEP MONITOR |
| Catalog Number | 22857-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-06-23 |