MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-24 for IMPELLA RP 004334 manufactured by Abiomed, Inc..
[70785570]
Patient Sequence No: 1, Text Type: N, H10
[70785571]
The impella rp device malfunctioned per the dr. And the product device representative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6431656 |
| MDR Report Key | 6431656 |
| Date Received | 2017-03-24 |
| Date of Report | 2017-03-08 |
| Date of Event | 2017-03-02 |
| Report Date | 2017-03-08 |
| Date Reported to FDA | 2017-03-08 |
| Date Reported to Mfgr | 2017-03-08 |
| Date Added to Maude | 2017-03-24 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA RP |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2017-03-24 |
| Model Number | 004334 |
| Catalog Number | 004334 |
| Device Expiration Date | 2017-03-31 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Manufacturer Address | 22 CHERRY HILL DR. DANVERS MA 01923 US 01923 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-24 |