MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-03 for IMPELLA VAD MOBILE CONSOLE 004603 manufactured by Abiomed, Inc.
[129026039]
During shift change the impella alarmed "controller error" with a message that stated to use back up controller. It was exchanged immediately. Device was sent to the vendor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8124035 |
| MDR Report Key | 8124035 |
| Date Received | 2018-12-03 |
| Date of Report | 2018-11-26 |
| Date of Event | 2018-11-04 |
| Report Date | 2018-11-26 |
| Date Reported to FDA | 2018-11-26 |
| Date Reported to Mfgr | 2018-12-03 |
| Date Added to Maude | 2018-12-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMPELLA VAD MOBILE CONSOLE |
| Generic Name | TEMPORARY CARDIAC SUPPORT BLOOD PUMP |
| Product Code | PBL |
| Date Received | 2018-12-03 |
| Returned To Mfg | 2018-11-05 |
| Model Number | 004603 |
| Device Availability | R |
| 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 | 2018-12-03 |