PERCUPUMP ARTICULATING ARM MOUNTING ACCESSORY

Description of Event or Problem

IT WAS REPORTED THAT THE CEILING MOUNT ARM BROKE AND FELL ON THE RADIOLOGY TECHNICIAN WHILE REMOVING THE IV LINE ON THE PT. THE TECHNICIAN WAS HIT ON THE BACK OF HER HEAD. SHE WAS ADMITTED BY EMERGENCY AND RELEASED APPROXIMATELY 3 HOURS LATER THE SAME DAY. THE TECHNICIAN DID NOT APPEAR TO HAVE SUFFERED ANY SERIOUS INJURY. AS OF 02/23/2007, THE TECHNICIAN HAD NOT REPORTED BACK TO WORK YET.

Additional Manufacturer Narrative

A REP FROM ANOTHER COUNTRY MFR VISITED THE USER FACILITY. THE HOSPITAL DID NOT ALLOW REMOVAL OF THE DEVICE; HOWEVER, DETAILED PICTURES WERE TAKEN FOR THE INVESTIGATION PROCESS. THIS ARTICULATING ARM WAS CONNECTOR TO AN OLDER INJECTOR UNIT WHICH IS NO LONGER MANUFACTURED. THE MODEL 5787 ARTICULATING ARM (MANUFACTURED BY MAVIG) IS NO LONGER IN MANUFACTURE. THE MODEL WAS ESTIMATED TO BE OVER 5 YEARS OLD. VISUAL ANALYSIS OF THE PHOTOS WAS PERFORMED BY REPS FROM MFR'S REGULATORY AND ENGINEERING DEPARTMENTS. THE POTENTIAL REASON FOR THIS FAILURE IS A RESULT OF REPEATING SWING OF THE ARM CONTACTING THE CEILING MOUNT COLUMN. A PIECE OF THE ARTICULATING ARM THAT BROKE OFF WAS STILL CONNECTED TO THE CEILING MOUNT. THE RIGID AREA OF THE ARTICULATING ARM COMES IN CONTACT WITH THE CEILING MOUNT COLUMN SLOWLY CAUSING THE ARM TO FRACTURE WHICH EVENTUALLY CAUSES BREAKAGE. THE ARTICULATING ARM FAILED DUE TO FATIGUE AND CONSTANT WEAR AND TEAR CONCENTRATED AT A SPECIFIC AREA. BASED ON THIS INVESTIGATION, THE LIKELY CAUSE IS DUE TO USER ABUSE, FATIGUE, AND WEAR AND TEAR OVER AN EXTENDED PERIOD. A REPLACEMENT ARM WAS SENT TO THE CUSTOMER. THE DESIGN OF THE REPLACEMENT IS STRONGER AND MORE ROBUST AND IS ABLE TO BETTER WITHSTAND USER ABUSE.