MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-08-12 for HEARTMATE II LVAS manufactured by Thoratec Corporation.
[22806688]
Patient Sequence No: 1, Text Type: N, H10
[22806689]
Persistent low flow alarms from device with clinical signs of decompensation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4997461 |
| MDR Report Key | 4997461 |
| Date Received | 2015-08-12 |
| Date of Report | 2015-07-21 |
| Date of Event | 2015-07-15 |
| Date Facility Aware | 2015-08-01 |
| Report Date | 2015-08-10 |
| Date Reported to FDA | 2015-08-10 |
| Date Reported to Mfgr | 2015-08-14 |
| Date Added to Maude | 2015-08-12 |
| 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 |
| 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 | HEARTMATE II LVAS |
| Generic Name | LVAD |
| Product Code | OKR |
| Date Received | 2015-08-12 |
| Device Availability | * |
| Device Age | 70 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2015-08-12 |