MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2020-02-10 for SYNCARDIA FREEDOM DRIVER 595000-001 manufactured by Syncardia Systems, Llc.
[178797543]
The freedom driver will be returned to syncardia for evaluation. The results of the investigation will be provided in a follow-up mdr. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[178797544]
The customer, a syncardia certified hospital, reported that the freedom driver exhibited a fault alarm while supporting a patient. The customer reported there were no abnormal patient observations. The customer reported the batteries were exchanged to see if they were the issue but the alarm continued. The customer also reported that the patient was switched to a back up freedom driver and there was no reported adverse patient impact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00055 |
| MDR Report Key | 9687100 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-18 |
| Date Mfgr Received | 2020-01-18 |
| Device Manufacturer Date | 2017-11-16 |
| Date Added to Maude | 2020-02-10 |
| 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 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 | 2020-02-10 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 595000-001 |
| Catalog Number | 595000-001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 AZ 85713 US 85713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-10 |