FDA.reportPublic FDA data

MAUDE MDR 274920

MDR report key
274920
Report number
2916596-2000-00011
Event key
0
Event type
3
Date of event
1997-05-23
Date received
2000-04-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
GARY CEDERWALL
Address
6035 STONERIDGE DR PLEASANTON CA 94588 US
Phone
925-925-9258
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEMVENTRICULAR ASSIST DEVICE, DUAL DRIVE CONSOLETHORATEC LABORATORIES, CORP.DSQNA10025-2601-007NAP8700YYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-04-170

Event Narratives#

D

Patient 1

A PT WITH LEFT AND RIGHT VENTRICULAR ASSIST DEVICES WAS BEING PREPARED TO BE TRANSFERRED FROM THE OPERATING ROOM AFTER IMPLANT, WHEN THE BOTTOM MODULE OF THE DUAL DRIVE CONSOLE SWITCHED OFF AS SOON AS THE AC POWER SUPPLY WAS DISCONNECTED. THERE WAS NO EFFECT ON THE PT. THE PT WAS TRANSPORTED FROM THE OPERATING ROOM USING THE TOP MODULE OF THE DUALDRIVE CONSOLE OPERATE BOTH VENTRICULAR ASSIST DEVICE.