MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-25 for IMPELLA CP CATHETER manufactured by Abiomed, Inc..
[125430069]
Motor failure on impella device, device alarmed. Impella cath removed due to cath malfunction. Balloon pump was put back in. No harm to pt but the balloon had to be reinserted due to equipment malfunction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080855 |
| MDR Report Key | 8009264 |
| Date Received | 2018-10-25 |
| Date of Report | 2018-10-24 |
| Date of Event | 2018-10-23 |
| Date Added to Maude | 2018-10-26 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | IMPELLA CP CATHETER |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2018-10-25 |
| Lot Number | 01008135022010879101356397 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-25 |