SUPPORT ARM 177
Received Aug 3, 2018 · Event occurred Jul 24, 2018
Report 8010042-2018-00405 · MDR key 7747400
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DAMAGED SUPPORT ARM WAS DISCARDED BY THE HOSPITAL. NO PARTS OR PICTURES WERE RECEIVED BACK FOR OUR INVESTIGATION. NO FURTHER INFORMATION WAS GIVEN TO CLARIFY WHERE THE DAMAGE WAS AND HOW THE DAMAGE OCCURRED. THEREFORE NO INVESTIGATION HAS BEEN POSSIBLE. WE ARE THEREFORE UNABLE TO PROVIDE, DETERMINE OR CONFIRM THE CAUSE OF THE REPORTED DAMAGE. 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) .