MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-26 for SYNCARDIA FREEDOM DRIVER 595000-001 manufactured by Syncardia Systems, Llc.
[181545806]
The customer-reported fault alarm at driver start-up was confirmed and reproduced during investigation testing. The primary motor did not operate due to a disconnected wire on the primary motor's printed circuit board assembly. Per design, the driver switched operation to the secondary motor which automatically triggers a permanent fault alarm. This issue will continue to be monitored and trended as part of the customer experience process. Syncardia has completed its investigation and is closing this file. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181545807]
The freedom driver was not supporting a patient. The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm upon start up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00076 |
| MDR Report Key | 9756509 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-12 |
| Date Mfgr Received | 2020-02-12 |
| Device Manufacturer Date | 2018-05-30 |
| Date Added to Maude | 2020-02-26 |
| 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 DRIVER |
| Generic Name | EXTERNAL PNEUMATIC DRIVER |
| Product Code | LOZ |
| Date Received | 2020-02-26 |
| Returned To Mfg | 2020-02-13 |
| Model Number | 595000-001 |
| Catalog Number | 595000-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-02-26 |