FDA.reportPublic FDA data

MAUDE MDR 220416

MDR report key
220416
Report number
2916596-1999-00004
Event key
0
Event type
3
Date of event
1999-03-24
Date received
1999-04-20
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, EMERGENCY HAND-BULB PUMPTHORATEC LABORATORIES CORP.DSQNA14787-2589-0005449YYY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11999-04-200

Event Narratives#

D

Patient 1

A HAND-BULB PUMP (NORMALLY USED TO PROVIDE EMERGENCY PNEUMATIC POWER TO A VENTRICULAR ASSIST DEVICE) WAS BEING USED IN THE OPERATING ROOM DURING IMPLANTATION, TO HAND PUMP THE VAD PRIOR TO ATTACHMENT TO THE PNEUMATIC DRIVER. THE USER HEARD A POPPING SOUND AND A HOLE WAS NOTED IN THE CIRCUMFERENCE OF THE BULB. ANOTHER HAND BULB WAS CONNECTED TO THE VAD AND THERE WAS NO EFFECT ON THE PT.