SUPPORT ARM
Received Aug 3, 2018 · Event occurred Jul 17, 2018
Report 8010042-2018-00404 · MDR key 7747249
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DAMAGED SUPPORT ARM WAS DISCARDED, THEREFORE IT WAS NOT RETURNED FOR OUR INVESTIGATION. A PICTURE OF THE BROKEN ARM WAS SENT. THE EVALUATION OF THE RETURNED PICTURE OF THE SUPPORT ARM SHOWS A BROKEN MOLDED SECTION AREA AT THE JOINT NEAREST TO THE BRACKET. HOWEVER, THE PICTURE DID NOT SHOW THE DATE STAMP THEREFORE THE MANUFACTURING DATE IS UNKNOWN. 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. PREVIOUS INVESTIGATIONS OF THE SUPPORT ARM LED TO 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 MAY 2009. 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 WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Additional Manufacturer Narrative
GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC (B)(4). CONTACT PERSON: (B)(4). OUR INVESTIGATION FOR THE COMPLAINT IS FINALIZED. THE DAMAGED SUPPORT ARM WAS DISCARDED, THEREFORE IT WAS NOT RETURNED FOR OUR INVESTIGATION. A PICTURE OF THE BROKEN ARM WAS SENT BY OUR FIELD SERVICE ENGINEER. THE EVALUATION OF THE RETURNED PICTURE OF THE SUPPORT ARM SHOWS A BROKEN MOLDED SECTION AREA AT THE JOINT NEAREST TO THE BRACKET. HOWEVER, THE PICTURE DID NOT SHOW THE DATE STAMP THEREFORE THE MANUFACTURING DATE IS UNKNOWN. 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. PREVIOUS INVESTIGATIONS OF THE SUPPORT ARM LED TO A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARM.
Description of Event or Problem
IMPORTER REF. #: (B)(4). MANUFACTURER REF. #: (B)(4).