MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-02-17 for HEARTPAK RECHARGEABLE BATTERIES 2025 manufactured by Thoratec Corp..
[1334342]
The pt was implanted with a left ventricular assist device (lvad). The circulatory support program coordinator reported that the pt charged the batteries overnight, went into the basement to get laundry and the batteries failed. The pt claimed that he alarmed and didn't have power to his lvad and nearly passed out. A warranty replacement set of batteries was shipped overnight to the pt at the time of the event.
Patient Sequence No: 1, Text Type: D, B5
[8490196]
The pt remains ongoing on lvad support with no further issues reported. The batteries were returned to the manufacturer and are currently being analyzed. A supplemental report will be submitted when the device analysis is completed. No further info is available at this time. Additional lot# mj2250.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2010-00040 |
| MDR Report Key | 1626101 |
| Report Source | 05,06 |
| Date Received | 2010-02-17 |
| Date of Report | 2010-01-19 |
| Date of Event | 2010-01-18 |
| Date Facility Aware | 2010-01-18 |
| Report Date | 2010-01-19 |
| Date Reported to Mfgr | 2010-01-19 |
| Date Mfgr Received | 2010-01-19 |
| Device Manufacturer Date | 2009-08-24 |
| Date Added to Maude | 2010-09-07 |
| 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 | 23 FOURTH AVE. |
| Manufacturer City | BURLINGTON MA 01803 |
| Manufacturer Country | US |
| Manufacturer Postal | 01803 |
| Manufacturer Phone | 7812720139 |
| Manufacturer G1 | THORATEC CORP. |
| Manufacturer Street | 6035 STONERIDGE DR. |
| 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 | HEARTPAK RECHARGEABLE BATTERIES |
| Generic Name | RECHARGEABLE BATTERIES |
| Product Code | MOY |
| Date Received | 2010-02-17 |
| Returned To Mfg | 2010-02-03 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | MJ225185 |
| ID Number | NA |
| Device Expiration Date | 2012-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORP. |
| Manufacturer Address | PLEASANTON CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-02-17 |