MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2007-09-14 for HEARTPAK RECHARGEABLE BATTERIES 2025 manufactured by Thoratec Corp..
[692592]
The patient was implanted with a left ventricular assist device (lvad). The patient reported that he received an audible alarm when connected only to the batteries. The patient also reported that he received a red heart alarm, pushed the reset alarm button and changed the batteries. The patient felt well and called his doctor. The surgeon decided to change the patient to backup support with no further issues. Later that day when the surgeon reviewed the log file, he found that the pump had stopped.
Patient Sequence No: 1, Text Type: D, B5
[7850218]
The manufacturer is attempting to acquire the batteries for further evaluation. The device manufacturer date and age of device are not available at this time since multiple battery lot numbers were received from the vendor on various dates. A supplemental report will be submitted when the device analysis is completed. No further information is available at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2007-00136 |
| MDR Report Key | 912463 |
| Report Source | 01,05,06 |
| Date Received | 2007-09-14 |
| Date of Report | 2007-08-24 |
| Date of Event | 2007-08-21 |
| Date Facility Aware | 2007-08-21 |
| Report Date | 2007-08-24 |
| Date Reported to Mfgr | 2007-08-24 |
| Date Mfgr Received | 2007-08-24 |
| Date Added to Maude | 2007-09-20 |
| 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 AVENUE |
| 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 | 2007-09-14 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | MG045005 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 887869 |
| Manufacturer | THORATEC CORP. |
| Manufacturer Address | PLEASANTON CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-09-14 |