MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-05-24 for PENGUIN NUTRITIONAL WARMER PNW-001-1.0 * manufactured by Neonatal Product Group, Inc.dba Creche Innovation.
[18847923]
Ac (alternating current) power cord was wired incorrectly on the new unit. It was found that the ground and neutral wires were reversed. ======================manufacturer response for breast milk warmer, penguin nutritional warmer (per site reporter). ======================the manufacturer was advised of the finding. They offered to replace all power cords. Out of 26 new units only 1 power cord was found defective.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2598442 |
| MDR Report Key | 2598442 |
| Date Received | 2012-05-24 |
| Date of Report | 2012-05-08 |
| Date of Event | 2012-05-08 |
| Report Date | 2012-05-08 |
| Date Reported to FDA | 2012-05-24 |
| Date Added to Maude | 2012-06-05 |
| 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 | PENGUIN NUTRITIONAL WARMER |
| Generic Name | BREAST MILK WARMER |
| Product Code | FPF |
| Date Received | 2012-05-24 |
| Model Number | PNW-001-1.0 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEONATAL PRODUCT GROUP, INC.DBA CRECHE INNOVATION |
| Manufacturer Address | 9243 CODY ST OVERLAND PARK KS 66214 US 66214 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-05-24 |