FDA Adverse Event
Malfunction
Summary report: N
SYNCARDIA COMPANION 2 DRIVER
MDR report key: 3982795
·
Received June 13, 2014
Report
- Report Number
- 3003761017-2014-00085
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- May 20, 2014
- Report Date
- June 12, 2014
- Manufacturer
- SYNCARDIA SYSTEMS, INC.
- Product Code
- LOZ
- PMA / PMN Number
- P030011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT APPROXIMATELY ONE MINUTE AFTER THE PT WAS SWITCHED TO THE COMPANION 2 DRIVER, THE DRIVER EXHIBITED A "SINGLE COMPRESSOR MALFUNCTION" ALARM. THE PT WAS SWITCHED TO A BACKUP COMPANION 2 DRIVER WITHOUT ADVERSE IMPACT. THIS ALLEGED FAILURE MODE POSES A LOW RISK TO THE PT BECAUSE IT DID NOT PREVENT THE COMPANION 2 DRIVER FROM PERFORMING ITS LIFE-SUSTAINING FUNCTIONS. THE COMPANION 2 DRIVER WILL BE RETURNED TO SYNCARDIA FOR EVAL. THE RESULTS OF THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL MDR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351148 | SYNCARDIA COMPANION 2 DRIVER | CIRCULATORY ASSIST DEVICE | LOZ | SYNCARDIA SYSTEMS, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |