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 IS DAMAGED. 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 RETURNED PICTURES SHOWS THAT THE SUPPORT ARM BROKE AT THE RAIL CLAMP. 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. THERE IS NO INFORMATION IF THE SUPPORT ARM HAS BEEN MANUFACTURED BEFORE OF AFTER IMPLEMENTED CHANGES. 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 ROOT CAUSE HAS BEEN MOST LIKELY RELATED TO USABILITY.

Description of Event or Problem

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