MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-06 for SYNCARDIA FREEDOM DRIVER 595000-001 manufactured by Syncardia Systems, Llc.
[177992453]
During investigation testing, the reported beat rate issue was reproduced. The root cause was determined to be a malfunction of the primary motor controller printed circuit board assembly (pcba). This issue will continue to be monitored and trended in the customer experience process. Syncardia has completed its evaluation of this complaint and is closing this file. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[177992534]
While performing functional testing, a syncardia technician reported that the freedom driver did not reach the specified beat rate values.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00052 |
| MDR Report Key | 9676896 |
| Report Source | OTHER |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-01-16 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2020-02-06 |
| 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 85713 |
| Manufacturer Country | US |
| Manufacturer Postal | 85713 |
| Manufacturer Phone | 5205451234 |
| Manufacturer G1 | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Street | 1992 E. SILVERLAKE ROAD |
| Manufacturer City | TUCSON AZ 85713 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85713 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCARDIA FREEDOM DRIVER |
| Generic Name | EXTERNAL PNEUMATIC DRIVER |
| Product Code | LOZ |
| Date Received | 2020-02-06 |
| Model Number | 595000-001 |
| Catalog Number | 595000-001 |
| 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 85713 US 85713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |