FDA.reportPublic FDA data

MAUDE MDR 1203586

MDR report key
1203586
Report number
2126677-2008-00084
Event key
0
Event type
3
Date of event
2008-09-17
Date received
2008-10-16
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, LLCIZZ45435245NANAY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-10-160

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE, THAT CAUSED THE TABLETOP TO UNEXPECTEDLY MOVE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (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 A MALFUNCTION IN THE MAIN POWER SUPPLY BOARD. THE FE REPLACED THE BOARD AND TESTED THE SYSTEM. THE TABLELOCKS WERE VERIFIED TO BE PERFORMING WITHIN SPECIFICATIONS.