MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-19 for BERLIN HEART manufactured by Berlin Heart.
[73490682]
Berlin vad noted by alarms and staff not to be functioning properly. Vad assessed to not be ejecting and patient with acute decompensation. Md and surgical team called to bedside and with immediate response and surgical intervention to change vad. Potential delamination of membrane noted by surgeon.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069239 |
| MDR Report Key | 6510794 |
| Date Received | 2017-04-19 |
| Date of Report | 2017-04-19 |
| Date of Event | 2017-02-15 |
| Date Added to Maude | 2017-04-21 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | BERLIN HEART |
| Generic Name | EXCOR VAD BERLIN HEART 15ML (VENTRICULAR ASSIST DEVICE) |
| Product Code | PCK |
| Date Received | 2017-04-19 |
| Lot Number | REF P15P-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERLIN HEART |
| Manufacturer Address | GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2017-04-19 |