MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-25 for PENGUIN PNW-001-1.0 * manufactured by Creche Innovations.
[3672202]
Stirring motor failed to operate causing non-function of device in its entirety. The manufacturer stated they would be looking into the issue. What was the original intended procedure? The intended procedure was to warm formula for patient use. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3253790 |
| MDR Report Key | 3253790 |
| Date Received | 2013-07-25 |
| Date of Report | 2012-11-19 |
| Date of Event | 2012-10-01 |
| Report Date | 2012-11-19 |
| Date Reported to FDA | 2013-07-25 |
| Date Reported to Mfgr | 2013-07-30 |
| Date Added to Maude | 2013-07-30 |
| 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 |
| Generic Name | WARMER, BREAST MILK/FORMULA |
| Product Code | FPF |
| Date Received | 2013-07-25 |
| Model Number | PNW-001-1.0 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRECHE INNOVATIONS |
| Manufacturer Address | 17745 METCALF, ONE PENGUIN PLA STILWELL KS 66085 US 66085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-25 |