| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | HEARTMATE EMERGENCY POWER PACK | EMERGENCY BATTERY PACK | THORATEC CORPORATION | DSQ | 2020 | 2020 | 55474 | N | Y | Y |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2007-05-31 | 0 | 1. R |
Patient 1
IT WAS REPORTED BY THE VAD COORDINATOR THAT WHILE THE PATIENT WAS AWAY FROM HOME AND ON PORTABLE BATTERY POWER, SHE RAN OUT OF POWER. SHE CONNECTED TO HER EMERGENCY POWER PACK (EPP) AND EXPERIENCED A FLASHING GREEN LIGHT ON THE CONTROLLER AND AN AUDIBLE TONE. THE PATIENT WENT TO THE HOSPITAL, AND THE VAD COORDINATOR DISCONNECTED THE BLACK LEAD FROM THE EPP AT WHICH TIME THE PUMP LOST POWER. PATIENT WAS THEN PLACED ON PORTABLE BATTERIES WITHOUT FURTHER INCIDENT.
Patient 1
THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE REPORTED EVENT WAS CONFIRMED. THE EVALUATION OF THE EMERGENCY POWER PACK (EPP) REVEALED A BROKEN BATTERY TERMINAL BETWEEN THE EPP AND THE PCB RESULTING IN LOSS OF POWER TO THE WHITE POWER LEAD. SUBSEQUENT EVALUATION OF THE BROKEN BATTERY TERMINAL REVEALED THE SOLDER CONNECTION OF THE PCB WIRE TO THE TERMINAL WAS INTACT; HOWEVER, IT APPEARED THAT THE TERMINAL WAS FRACTURED ADJACENT TO THE SOLDER JOINT CONSISTENT TO DAMAGE RESULTING IN EXCESS MOVEMENT OR FLEXING. THE EVALUATION COULD NOT CONCLUSIVELY DETERMINE IF THE BATTERY TERMINAL DAMAGE OCCURRED DURING USE OR POTENTIALLY DURING THE ASSEMBLY PROCESS. A REVIEW OF DEVICE HISTORY RECORDS SHOWED THERE WERE NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.