MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-03-21 for HEARTMATE RECHARGEABLE BATTERIES 2025 manufactured by Thoratec Corp..
[591738]
The pt was implanted with a vented electric left ventricular assist device (lvad). It was reported by the clinical engineer that the pt was being changed from battery support to the power base unit (pbu) in the clinic. When the pt was removed from the first battery, she experienced a red battery alarm, which was followed by a red heart alarm approx two seconds later. The pump was off for three seconds until the power was reconnected.
Patient Sequence No: 1, Text Type: D, B5
[7820725]
The manufacturer is attempting to obtain in the device for evaluation. The pt remains ongoing on lvad support. No further info is available at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2007-00046 |
| MDR Report Key | 833554 |
| Report Source | 05,06 |
| Date Received | 2007-03-21 |
| Date of Report | 2007-03-21 |
| Date of Event | 2007-01-23 |
| Date Facility Aware | 2007-01-23 |
| Report Date | 2007-03-21 |
| Date Reported to FDA | 2007-03-08 |
| Date Reported to Mfgr | 2007-03-21 |
| Date Mfgr Received | 2007-03-21 |
| Date Added to Maude | 2007-04-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | ROBERT FRYC |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9258478600 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE RECHARGEABLE BATTERIES |
| Generic Name | RECHARGEABLE BATTERIES |
| Product Code | MOY |
| Date Received | 2007-03-21 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | MG087009 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 820875 |
| Manufacturer | THORATEC CORP. |
| Manufacturer Address | * PLEASANTON CA * US |
| Baseline Brand Name | HEARTMATE RECHARGABLE BATTERY |
| Baseline Generic Name | RECHARGABLE BATTERIES |
| Baseline Model No | 2025 |
| Baseline Catalog No | 2025 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-03-21 |