MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-04 for * 42 manufactured by Natus Medical.
[14925991]
A smell was noticed by staff in "blue" hallway of nicu. Rn and cna tried to locate source and could not. Rn stated it smelled most in one room. When rn went into room she noticed a small stream of white smoke coming from the top of unit's control box. The unit was unplugged and removed from the patient's room. The smoke had stopped and they watched the unit for ten minutes at the front desk with no further smoke seen. Biomed comments: smoke was due to the fuse holder burning up. Possible arching causing fuse holder to burn away. Replaced fuse holder and fuse. Performed safety and operational test.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2299388 |
| MDR Report Key | 2299388 |
| Date Received | 2011-10-04 |
| Date of Report | 2011-10-04 |
| Date of Event | 2011-08-23 |
| Report Date | 2011-10-04 |
| Date Reported to FDA | 2011-10-04 |
| Date Added to Maude | 2011-10-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | HEATING, LAMP |
| Product Code | ILY |
| Date Received | 2011-10-04 |
| Model Number | 42 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 14 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL |
| Manufacturer Address | 5900 FIRST AVE S SEATTLE WA 98108324 US 98108 3249 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-04 |