FDA.reportPublic FDA data

MAUDE MDR 1301933

MDR report key
1301933
Report number
MW5009788
Event key
0
Event type
3
Date of event
2009-01-15
Date received
2009-01-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1104181 EASYDIAGNOST 9" II DSI-UX-RAY TUBE AND FLOURO TOWERPHILIPS MEDICAL SYSTEMS NORTH AMERICAITY Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-01-290

Event Narratives#

D

Patient 1

DIAGNOSTIC RADIOLOGY UNIT HAS A BUTTON THAT, WHEN PUSHED, ALLOWS THE TABLE TO BE TILTED BY TURNING A LEVER. THE BUTTON IS SUCH THAT IT CAN EASILY BE PUSHED WITHOUT THE USERS KNOWLEDGE. ALSO, WHEN PUSHED, THE BUTTON REMAINS ACTIVATED UNTIL IT IS PUSHED AGAIN TO UNACTIVATE. THERE IS NO "TIME-OUT" OR REMINDER TO THE USER THAT THE BUTTON IS ACTIVATED. IN THIS CASE, THE BUTTON WAS ACTIVATED FROM A PREVIOUS PATIENT, AND WAS NOT TURNED OFF BY THE RADIOLOGY TECHNOLOGIST. AS THE TECH WAS MOVING THE X-RAY TUBE AROUND THE FLOURO TOWER, THE POWER CABLES TO THE TUBE CAUGHT THE TABLE TILT LEVER, TILTED THE TABLE DOWN AND THE PATIENT SLID OFF THE TABLE TO THE FLOOR. NOTE: PHILIPS CHECKED THE EQUIPMENT AND FOUND IT IS WORKING AS DESIGNED. OUR BIOMED DEPARTMENT DEVELOPED A RAISED AREA AROUND THE BUTTON AND A PLEXIGLASS COVER OVER THE TILT LEVER TO PREVENT THEIR ACCIDENTALLY BEING ACTIVATED.