FDA Adverse Event Malfunction Summary report: N

MD4 VASCULAR SYSTEM

MDR report key: 3112272 · Received May 2, 2006

Report

Report Number
3112272
Event Type
Malfunction
Date Received
May 2, 2006
Date of Event
April 24, 2006
Report Date
May 2, 2006
Manufacturer
PHILLIPE MEDICAL SYSTEMS OF NORTH AMERICA
Product Code
JAA
Product Problem
Yes
Report Source
User Facility report
Reporter Location
NC, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

CONCERNS REP, THE LACK OF A SAFETY RELEASE ON THE II WHEN IT ENCOUNTERS A COLLISION. WHEN THE II ENCOUNTERS EVEN LIGHT RESISTANCE, IT BOUNCES AWAY. THIS ONE LOCKS IN POSITION, WHETHER ON A PATIENT'S ARM, BACK, OR WHATEVER IT HAS ENCOUNTERED. THIS HAS BEEN A SERIOUS CONCERN BECAUSE WE HAVE TO SWING INTO AP AND LATERAL POSITION, SO OF TEN DURING KYPHOPLASTIES. THE CANNULA IS IN PLACE. WE WATCH LIKE HAWKS AS THE UNIT IS SWINGING BECAUSE IF IT HITS THE CANNULA AND LOOKS, IT COULD PUSH IT THROUGH THE VERTEBRAL BODY INTO THE AORTA, LUNG, ETC. THE UNIT TOUCHED THE PATIENT'S ARM AND LOOKED. THE RT HIT THE CLEAR BUTTON. THE C ARM THEN 'WILDLY' BEGAN TO SWING INTO A LATERAL CC SKEWED POSITION TOWARDS RADIOLOGIST'S LOG, THEN BEGAN MOVING DOWN THE LENGTH OF THE TABLE PINNING THE RADIOLOGIST BETWEEN THE TUBE AND THE CONTROL PANEL. WE THOUGHT SOMEONE WAS IN THE CONTROL AREA BUT WHEN WE LOOKED, THERE WASN'T, SO RT QUICKLY AND FORTUNATELY YANKED THE CONTROL PANEL OFF THE RAIL JUST AS IT WAS GETTING UNCOMFORTABLE. QUESTION IF THE BUTTON FOR RELEASING THE TUBE "STUCK", BUT UNABLE TO EXPLAIN THE ODD POSITION IT ASSUMED AND CONTINUAL MOVEMENT DOWN THE TABLE AGAINST RESISTANCE. WE KNOW THERE IS A SAFETY RELEASE ON THE TOP OF THE TUBE, BUT NOT ON THE SIDE (WHICH PINNED RADIOLOGIST), OR ON THE II ITSELF. THE LATTER IS THE SOURCE OF THE PROBLEM. IF IT HAD RELEASED WHEN IT HIT THE PATIENT'S ARM, WE WOULD NOT HAVE HAD TO HIT THE OTHER RELEASE BUTTON.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MD4 VASCULAR SYSTEM C-ARM JAA PHILLIPE MEDICAL SYSTEMS OF NORTH AMERICA 101759

Patients

Seq Age Sex Outcome Treatment
1