SUPPORT ARM 176

Description of Event or Problem

IT WAS REPORTED THAT THE SUPPORT ARM HOLDING THE PATIENT CIRCUIT BROKE. PATIENT INVOLVEMENT IS UNKNOWN. MANUFACTURER'S REF #: (B)(4).

Additional Manufacturer Narrative

IT WAS CLAIMED THAT SUPPORT ARM NEEDS TO BE REPLACED. THE DEVICE FAILED TO MEET ITS SPECIFICATIONS, IT IS UNKNOWN IF IT HAS BEEN USED AT THE TIME OF THE EVENT. THERE HAVE BEEN NO ADVERSE EVENT SUSTAINED AS A RESULT OF THE ISSUE. THE EVALUATION OF THE PROVIDED INFORMATION REVEALED THAT WHOLE ARM HAS BEEN DAMAGED. THE SUPPORT ARM IS CAST AND HAS MOST LIKELY PREVIOUSLY CRACKED AT AN EARLIER OCCASION EITHER BY OVERLOADING OR IMPACT, THE CRACK WIDENED AND THIS LED TO THE REPORTED BREAKAGE. PREVIOUS INVESTIGATIONS LED TO A REDESIGN AND A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THIS CHANGE WAS IMPLEMENTED IN PRODUCTION DURING SEPTEMBER 2009. ACCORDING TO INFORMATION PROVIDED BY THE TECHNICIAN, A GREY COLOR OF COVER ON SUPPORT ARM'S JOINT REVEALED THAT THE PART HAS BEEN MANUFACTURED AFTER DESIGN IMPLEMENTATION. IN THE INSTALLATION MANUAL FOR THE SUPPORT ARM 176 IN THE SPECIFICATION OF THE MAXIMUM CAPACITY, IT IS STATED HOW MANY KILOGRAMS CAN BE LOADED DEPENDING ON THE ANGLE OF USE OF THE ACCESSORIES (MAX. APPROX. 3 KG). THE MOST LIKELY ROOT CAUSE IS RELATED TO USABILITY.

Description of Event or Problem

MANUFACTURER'S REF #: (B)(4).