MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,health profe report with the FDA on 2019-11-30 for CARDIOHELP-I 70104.8012 manufactured by Maquet Cardiopulmonary Gmbh.
| Report Number | 8010762-2019-00381 |
| MDR Report Key | 9392252 |
| Report Source | CONSUMER,FOREIGN,HEALTH PROFE |
| Date Received | 2019-11-30 |
| Date of Report | 2019-11-29 |
| Date of Event | 2019-10-20 |
| Date Mfgr Received | 2019-10-21 |
| Device Manufacturer Date | 2010-09-15 |
| Date Added to Maude | 2019-11-30 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 4972229321 |
| Manufacturer G1 | NURSEL BOELENS |
| Manufacturer Street | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76437 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDIOHELP-I |
| Generic Name | CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS |
| Product Code | DTQ |
| Date Received | 2019-11-30 |
| Model Number | CARDIOHELP-I |
| Catalog Number | 70104.8012 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY GMBH |
| Manufacturer Address | NEUE ROTTENBURGER STRASSE 37 HECHINGEN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-30 |