FDA.reportPublic FDA data

MAUDE MDR 561422

MDR report key
561422
Report number
561422
Event key
0
Event type
3
Date of event
2003-12-15
Date received
2004-01-13
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
1OPERON B810OPERATING TABLEBERCHTOLD CORPORATIONFSEOPERON B810B810 075-1003 048*NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-01-130

Event Narratives#

D

Patient 1

DURING A ROUTINE ADJUSTMENT OF THE OR OPERATING ROOM TABLE USING THE REGULAR PENDANT THE TABLE MALFUNCTIONED AND THE HEAD END CONTINUED TO LOWER. THE PATIENT ENDED UP WITH THEIR HEAD DOWN NEAR THE FLOOR AND STAFF HAD TO KEEP PT FROM SLIPPING OFF THE TABLE. THE TABLE WAS IN SUCH AN ORIENTATION THAT THE MANUAL FOOT PUMP AND PENDANT IN THE BASE COULD NOT BE ACCESSED. AFTER A FEW MINUTES THE TABLE WAS LEVELED USING THE REGULAR PENDANT AND STOOLS WERE PLACED UNDER THE HEAD END TO PREVENT A RECURRENCE. THE CASE WAS FINISHED WITHOUT FURTHER INCIDENT.