inforMED
MalfunctionIXK

SHIMADZU HS-10A

Received Sep 30, 1994 · Event occurred Sep 2, 1994

Report 38771-1994-09001 · MDR key 19549

Device

Generic name

Urological X-ray System

Model number

HS-10A

Catalog number

HS-10A

Lot number

NA

Patient

*

Narrative

Description of Event or Problem

HOSPITAL ADVISED DISTRIBUTOR ON 9/2/94 THAT THE TABLE HAD TILTED TO 90 DEGREES BY ITSELF. ANESTHESIOLOGIST WAS INJURED TRYING TO KEEP PT FROM FALLING WHEN TABLE TILTED. TECHNICIAN INVOLVED IN THE INCIDENT REPORTED TO COPORATION'S SENIOR IMAGING SPECIALIST THAT THE TABLE WOULD NOT MOVE LATERALLY USING THE FOOTSWITCH. DURING REMOVAL OF THE PT FROM THE TABLE, IT BEGAN TILTING AND WOULD NOT RESPOND TO THE FOOTSWITCH.