MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for ABIOMED IMPELLA CP 42413 manufactured by Abiomed, Inc..
[177550559]
On (b)(6) 2020, impella implanted; (b)(6) 2020, the device required repositioned. After the catheter was repositioned and placement was confirmed correct, the device started alarming with the following message. Placement signal not reliable. Placement signal and suction monitoring and suspended. Monitor pt hemodynamics and impella position with imaging; check the pt cable for kinks. Call placed to the impella rep (b)(6) for guidance. The pt had an unusual wave form. On (b)(6) 2020 pt expired and device was removed and released to the impella rep. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092675 |
| MDR Report Key | 9659183 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-29 |
| Date of Event | 2020-01-22 |
| Date Added to Maude | 2020-02-03 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | ABIOMED IMPELLA CP |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2020-01-31 |
| Model Number | 42413 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABIOMED, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-31 |