MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-08-28 for HEARTPAK RECHARGEABLE BATTERIES 2025 manufactured by Thoratec Corp..
[539211]
The patient was implanted with the manufacturer's clinical trial lvad. It was reported by the cardiovascular perfusionist that the patient attempted to change batteries prior to a physical therapy session by removing one battery from the batter clip and replacing it with a new one; however, the patient failed to click the battery back into place within the battery clip. The patient proceeded to remove the second battery resulting in power loss to the system since the first battery was not placed correctly and a red heart alarm was experienced. The patient passed out and was unresponsive. At this time, a nurse assessed the batteries and secured them in place and restarted the pump, the patient became responsive and stable.
Patient Sequence No: 1, Text Type: D, B5
[7798806]
The patient remains on lvas support and was placed in a rehab facility and both the staff and the patient were re-educated in how to change the batteries. No further information is available at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916596-2006-00134 |
| MDR Report Key | 755008 |
| Report Source | 05,06 |
| Date Received | 2006-08-28 |
| Date of Report | 2006-07-26 |
| Date of Event | 2006-07-26 |
| Date Facility Aware | 2006-07-26 |
| Report Date | 2006-07-26 |
| Date Reported to Mfgr | 2006-07-26 |
| Date Mfgr Received | 2006-07-26 |
| Date Added to Maude | 2006-08-29 |
| 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 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 | HEARTPAK RECHARGEABLE BATTERIES |
| Generic Name | RECHARGEABLE BATTERIES |
| Product Code | MOY |
| Date Received | 2006-08-28 |
| Model Number | 2025 |
| Catalog Number | 2025 |
| Lot Number | MG131012 |
| ID Number | * |
| Device Expiration Date | 2009-04-30 |
| 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 | 742822 |
| Manufacturer | THORATEC CORP. |
| Manufacturer Address | * PLEASANTON CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-08-28 |