MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2020-03-30 for PANDA IRES WARMER M1112198-503922 manufactured by Datex-ohmeda, Inc..
| Report Number | 2112667-2020-01073 |
| MDR Report Key | 9899216 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-12-12 |
| Date Mfgr Received | 2019-12-12 |
| Device Manufacturer Date | 2017-11-13 |
| Date Added to Maude | 2020-03-30 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAVID WOODWORTH |
| Manufacturer Street | 3030 OHMEDA DRIVE |
| Manufacturer City | MADISON, WI |
| Manufacturer Country | US |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | SEEH10 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PANDA IRES WARMER |
| Generic Name | WARMER, INFANT RADIANT |
| Product Code | FMT |
| Date Received | 2020-03-30 |
| Model Number | M1112198-503922 |
| Lot Number | PBWW62697 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DATEX-OHMEDA, INC. |
| Manufacturer Address | 3030 OHMEDA DR, MADISON, WI 53718 US 53718 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |