FDA.reportPublic FDA data

MAUDE MDR 668099

MDR report key
668099
Report number
668099
Event key
0
Event type
3
Date of event
2005-08-19
Date received
2005-12-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKCEILING SUSPENSION SYSTEMTI-BA ENTERPRISES, INC. (MAVIG GMBH)IYB***NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-12-130
22005-12-130

Event Narratives#

D

Patient 1

WHILE THE PATIENT WAS BEING DRAPED FOR THE PROCEDURE, THE X-RAY ARM BROKE AND FELL OFF FROM THE CEILING SUSPENSION SYSTEM STRIKING THE CATH LAB TECH ON THE SHOULDER. THE TECH HAD LIFTED THE SHIELD PART OF THE X-RAY ARM UP WHEN THE UPPER PART OF THE ARM BROKE FALLING TO THE GROUND. THE PATIENT WAS NOT STRUCK BY THE ARM NOR WERE THEY INJURED IN ANY WAY. THIS WAS THE FOURTH OCCURRENCE OF THIS TYPE EXPERIENCED BY FACILITY. MAVIGG REPLACED ALL CEILING SUSPENSION SYSTEMS IN THIS FACILITY IN SEPTEMBER, 2005 WITH A STEEL VERSION OF THE PRODUCT AND THERE HAVE BEEN NO ADDITIONAL INCIDENTS SINCE THE EQUIPMENT WAS REPLACED.