FDA.reportPublic FDA data

MAUDE MDR 1418666

MDR report key
1418666
Report number
2126677-2009-00024
Event key
0
Event type
3
Date of event
2009-03-06
Date received
2009-04-01
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
MARTHA KAMROW
Address
3000 N GRANDVIEW BLVD. WAUKESHA WI 53188 US
Phone
262-262-2623
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COMPAX 40EGE MEDICAL SYSTEMS, LLCIZZ2133494NANAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-04-010

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE WHEN THE FOOT PEDAL WAS RELEASED, CAUSING THE TABLETOP TO UNEXPECTEDLY MOVE WITHOUT RESISTANCE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS (FREE FLOAT). THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.

N

Patient 1

THE GE FIELD ENGINEER (FE) FOUND THAT THE UNEXPECTED FLOAT WAS A RESULT OF A POWER LOSS TO THE TABLE LOCKS DUE TO A BLOWN FUSE. THE FE REPLACED THE FUSE AND VERIFIED THAT THE TABLE LOCKS WERE WORKING AS EXPECTED.