MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-24 for NOX T3, NOXTURNAL T3 SLEEP MONITOR 69443 manufactured by Nox Medical.
[32209636]
(b)(4). Any additional information received from the customer will be included in a follow up report. (b)(4). The device has not been received by carefusion.
Patient Sequence No: 1, Text Type: N, H10
[32209637]
The customer reported that her sleep technician placed batteries in the t3 sleep monitoring device and placed it on her finger to ensure that it was working properly, when she did this the device did not come on, but she reported smelling a "burning" smell and the back housing of the device became "very warm. " she then removed the device off of her finger and took out the batteries. When she removed the batteries they were very hot and she could not hold them in her hand so she "dropped" them onto the counter. The customer reported no patient involvement or allegation of patient harm. At this time, carefusion has not received the suspect device for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[38889334]
Additional information received indicating initial medwatch was filed in error as device was not manufactured by (b)(4). The legal manufacturer of the complainant device is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2021710-2015-02297 |
| MDR Report Key | 5247848 |
| Date Received | 2015-11-24 |
| Date of Report | 2015-11-09 |
| Date of Event | 2015-10-28 |
| Date Mfgr Received | 2016-02-03 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2015-11-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 1100 BIRD CENTER DRIVE IS 112 |
| Manufacturer City | PALM SPRINGS CA 92262 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92262 |
| 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 | 2015-11-24 |
| Model Number | T3 SLEEP MONITOR |
| Catalog Number | 69443 |
| Lot Number | 904003664 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOX MEDICAL |
| Manufacturer Address | IMPRA KELDNAHOLTI IS 112 REYKJAVIK IC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-24 |