MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-09 for BERLIN HEART BERLIN HEART 15CC PUMP manufactured by Berlin Heart, Inc..
[182546660]
Our patient with a berlin heart had a pump that was making a crunching noise. Video and picture of the pump were taken and sent to berlin heart to assess. Initially we were told that no interventions were needed. The following day, we received a call from berlin heart and were told that after they further assessed the video and images of the pump, we should change it out. So the pump was exchanged with no issues or harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9805365 |
| MDR Report Key | 9805365 |
| Date Received | 2020-03-09 |
| Date of Report | 2019-12-20 |
| Date of Event | 2019-12-16 |
| Report Date | 2019-12-20 |
| Date Reported to FDA | 2019-12-20 |
| Date Reported to Mfgr | 2020-03-09 |
| Date Added to Maude | 2020-03-09 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 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 | BERLIN HEART |
| Generic Name | BERLIN HEART |
| Product Code | PCK |
| Date Received | 2020-03-09 |
| Returned To Mfg | 2019-12-18 |
| Model Number | BERLIN HEART 15CC PUMP |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BERLIN HEART, INC. |
| Manufacturer Address | 9391 GROGANS MILL ROAD SUITE A6 THE WOODLANDS TX 77380 US 77380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-09 |