MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-05 for ALICE NIGHTONE 113277 UNK manufactured by Philips Respironics.
[57717157]
Patient reported that she sustained a burn to her chest from an alice nightone monitor for an at home sleep study. The event took place on (b)(6) 2016 at the patient's home. The patient reported that she was given the device to use during a at home sleep study. The device is called an alice nightone and is manufactured by philips. The patient claims that the device sparked at some point. The patient stated that she went to sleep and when she woke up she had a burn underneath the device. The burn is described as a 2x2 centimeter circular burn located on the right center of the patient's chest. The burn is full thickness.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6033987 |
| MDR Report Key | 6033987 |
| Date Received | 2016-10-05 |
| Date of Report | 2016-10-03 |
| Date of Event | 2016-09-22 |
| Date Facility Aware | 2016-09-22 |
| Report Date | 2016-10-03 |
| Date Reported to FDA | 2016-10-03 |
| Date Reported to Mfgr | 2016-10-03 |
| Date Added to Maude | 2016-10-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALICE NIGHTONE |
| Generic Name | SLEEP STUDY MONITOR |
| Product Code | MNR |
| Date Received | 2016-10-05 |
| Model Number | 113277 |
| Catalog Number | UNK |
| Lot Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS RESPIRONICS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-10-05 |