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.
[181547114]
The freedom driver has 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
[181547115]
The customer, a syncardia certified hospital, reported that the freedom driver exhibited intermittent fault alarms while supporting a patient. The customer also reported that the patient had actually switched to a backup freedom driver about a month ago (~01/23/2020) because the reported freedom driver was having intermittent fault alarms every morning which would eventually resolve on their own. There was no reported adverse patient impact at the time the driver was switched. The customer also reported that the reported freedom driver was obtained from the patient and replaced with a backup driver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003761017-2020-00075 |
| MDR Report Key | 9759392 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-26 |
| Date of Report | 2020-02-24 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2017-11-13 |
| 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 | 2020-02-14 |
| Model Number | 595000-001 |
| Catalog Number | 595000-001 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 |