MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-21 for SYNCARDIA FREEDOM ONBOARD BATTERY 295025-001 manufactured by Syncardia Systems, Llc.
[181547277]
The freedom onboard battery was returned from the field for evaluation and failed op 030 for functional evaluation in accordance with mfg-191, freedom onboard battery evaluation procedure. Led's did not illuminate and smbus data did not display unless put into the charger. Also the battery could not be discharged for storage. This was not an out of box failure. Results of the investigation showed signs of impact shock on the right side of the holding tab of the freedom onboard battery. As a part of the investigation, a second evaluation of the battery was performed in accordance with mfg-191, freedom onboard battery evaluation procedure. The functional evaluation found a failure to activate the smbus data by battery power. The smbus data was activated only when external power was connected and it showed that the battery had an unspecified permanent fault, likely as a result of impact shock. Syncardia has completed its evaluation of this complaint and is closing this file. If new or additional information is received in the future, syncardia will file a follow up mdr. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181547278]
While performing routine freedom onboard battery evaluation, a syncardia technician reported that the onboard battery gas gauge leds did not illuminate, smbus data did not display if not put into the charger, and the battery could not be discharged for storage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00067 |
| MDR Report Key | 9741981 |
| Report Source | OTHER |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-01-28 |
| Device Manufacturer Date | 2018-07-03 |
| Date Added to Maude | 2020-02-21 |
| 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 | MS. KERRI HENSLEY |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON, AZ |
| Manufacturer Country | US |
| Manufacturer Phone | 5451234120 |
| Manufacturer G1 | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON, AZ |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCARDIA FREEDOM ONBOARD BATTERY |
| Generic Name | BATTERY |
| Product Code | LOZ |
| Date Received | 2020-02-21 |
| Model Number | 295025-001 |
| Catalog Number | 295025-001 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Address | 1992 E. SILVERLAKE ROAD TUCSON, AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-21 |