SUPPORT ARM 177

Additional Manufacturer Narrative

NO PARTS WERE RETURNED. THE BROKEN SUPPORT ARM WAS DISCARDED BY THE USER FACILITY. INVESTIGATION WAS BASED ON PICTURE RECEIVED. ACCORDING TO THE PICTURE, THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. THE SUPPORT ARM IS A CASTING AND IT MOST PROBABLY DEVELOPED A CRACK AT AN EARLIER OCCASION EITHER BY OVERLOADING OR IMPACT AND THIS LED TO THE REPORTED BREAKING. THE SUPPORT ARM HAS BEEN SUCCESSFULLY TESTED FOR MECHANICAL STRENGTH AND IS DESIGNED ACCORDING TO STANDARD. IT IS UNKNOWN UNDER WHICH CIRCUMSTANCES THE SUPPORT ARM BROKE. PREVIOUS INVESTIGATIONS OF SIMILAR FAULTS LED TO A REDESIGN AND CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM. THE SUPPORT ARM ASSOCIATED WITH THIS COMPLAINT HAD BEEN MANUFACTURED BEFORE THIS CHANGE WAS IMPLEMENTED IN PRODUCTION. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC 45 BARBOUR POND DRIVE WAYNE, NJ 07470. CONTACT PERSON: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE SUPPORT ARM BROKE AT THE LOWER END. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).