MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-09-15 for COOL-CAP * manufactured by Natus Medical Incorporated.
[15144285]
An electrical burning odor was noted at 0500. Staff swapped out open warmer, at approximately 1320 the electrical burning odor was once again noted at the bedspot. Clinical engineering was called and about ten minutes later a popping noise (three quick pops) was heard and the screen on the cool cap machine went blank and the machine stopped functioning. The infant was immediately taken off the cool cap and moved to another bedspot. To maintain therapy the infant was transported to another facility that could offer cooling therapy. ======================manufacturer response for hypothermia units, infant, head, cool-cap (per site reporter). ======================manufacturer provided rga# for device return evaluation and repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2269770 |
| MDR Report Key | 2269770 |
| Date Received | 2011-09-15 |
| Date of Report | 2011-09-15 |
| Date of Event | 2011-09-10 |
| Report Date | 2011-09-15 |
| Date Reported to FDA | 2011-09-15 |
| Date Added to Maude | 2011-09-29 |
| 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 | COOL-CAP |
| Generic Name | CAP, COOLING |
| Product Code | MXM |
| Date Received | 2011-09-15 |
| Returned To Mfg | 2011-09-13 |
| Model Number | COOL-CAP |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | 3.5 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MEDICAL INCORPORATED |
| Manufacturer Address | 5900 FIRST AVE. SOUTH SEATTLE WA 98108 US 98108 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-15 |