MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for SYNCARDIA FREEDOM DRIVER manufactured by Syncardia Systems, Llc.
[185055502]
Freedom driver tipped over when patient was getting back to bed. Device did not alarm. Hours later patient called to staff that she wasn't feeling well. Staff and patient could smell electrical burning from machine and machine feels hot to touch. Moments later, device failed and patient coded. Back up device connected to patient and patient fully recovered following brief intubation. Manufacturer response for freedom driver tah, freedom driver (per site reporter). Manufacturer has asked for device to be returned so they can interrogate machine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882505 |
| MDR Report Key | 9882505 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-20 |
| Date of Event | 2020-02-01 |
| Report Date | 2020-02-20 |
| Date Reported to FDA | 2020-02-20 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYNCARDIA FREEDOM DRIVER |
| Generic Name | ARTIFICIAL HEART |
| Product Code | LOZ |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2020-02-24 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNCARDIA SYSTEMS, LLC |
| Manufacturer Address | 1992 E. SILVERLAKE RD TUSCON AZ 85713 US 85713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-26 |