FDA Adverse Event
Other
Summary report: N
NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM
MDR report key: 1215647
·
Received October 14, 2008
Report
- Report Number
- 2916284-2008-00005
- Event Type
- Other
- Date Received
- October 14, 2008
- Date of Event
- October 12, 2008
- Report Date
- October 14, 2008
- Manufacturer
- WORLD HEART, INC.
- Product Code
- DSQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Description of Event or Problem · 1
THE RECIPIENT WHO WAS OUT SHOPPING NOTED "CHECK" LIGHT AND ALARM TONE FROM CONTROLLER, AND NOTED THAT PUMP SOUNDS HAD STOPPED. HE WAS NOT CARRYING A BACKUP CONTROLLER. (NOTE THE RECIPIENT'S GUIDE ADVISES: "ALWAYS CARRY AN EXTRA CONTROLLER AND TWO POWER PACKS.") RECIPIENT RETURNED HOME AND REPLACED THE CONTROLLER. PUMP SOUNDS WERE NORMAL AND THERE WERE NO FURTHER ALARMS. FOLLOW-UP AT HOSPITAL CONFIRMED NORMAL SYSTEM OPERATION, NO FURTHER ALARMS, AND NO CLINICAL ADVERSE EVENTS. RECIPIENT WAS OBSERVED FOR 20 HOURS IN HOSPITAL, THEN RETURNED HOME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NOVACOR N100 LEFT VENTRICULAR ASSIST SYSTEM | CONTROLLER, NOVACOR PLUS | DSQ | WORLD HEART, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |