FDA Adverse Event
Malfunction
Summary report: N
SYNCARDIA COMPANION 2 DRIVER
MDR report key: 3820642
·
Received May 7, 2014
Report
- Report Number
- 3003761017-2014-00067
- Event Type
- Malfunction
- Date Received
- May 7, 2014
- Date of Event
- April 28, 2014
- Report Date
- May 6, 2014
- Manufacturer
- SYNCARDIA SYSTEMS, INC.
- Product Code
- LOZ
- PMA / PMN Number
- P030011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE "RIGHT VACUUM INCORRECT" ALARM WOULD SHOW PERIODICALLY ON THE SCREEN OF THE COMPANION 2 DRIVER. THE PATIENT WAS SWITCHED TO A BACKUP DRIVER WITHOUT ADVERSE IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PATIENT BECAUSE IT DOES NOT PREVENT THE COMPANION DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. AN INVESTIGATION WILL BE CONDUCTED BY SYNCARDIA. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 276745 | SYNCARDIA COMPANION 2 DRIVER | CIRCULATORY ASSIST DRIVER | LOZ | SYNCARDIA SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | NA. |