MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-29 for BERLIN HEART EXCOR DEVICE D031-111X01 manufactured by Berlin Heart Gmbh.
[61234297]
Defect in berlin heart machine, requiring patient to undergo surgery to have machine swapped out. Dates of use: (b)(6) 2016. Reason for use: dilated cardiomyopathy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5066380 |
| MDR Report Key | 6135036 |
| Date Received | 2016-11-29 |
| Date of Report | 2016-11-29 |
| Date of Event | 2016-11-23 |
| Date Added to Maude | 2016-11-30 |
| 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 | BERLIN HEART EXCOR DEVICE |
| Generic Name | BERLIN HEART EXCOR DEVICE |
| Product Code | PCK |
| Date Received | 2016-11-29 |
| Returned To Mfg | 2016-11-29 |
| Catalog Number | D031-111X01 |
| ID Number | 09-2950 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERLIN HEART GMBH |
| Manufacturer Address | BERLIN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-11-29 |