SUPPORT ARM 177
Received Jan 26, 2016
Report 8010042-2016-00039 · MDR key 5391086
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(6) 2016 01:57 PM (GMT-5:00) ADDED BY (B)(6) ((B)(4)): FURTHER INFORMATION REGARDING THE EVENT HAS BEEN SOUGHT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.
Description of Event or Problem
IT WAS REPORTED THAT THE SUPPORT ARM FOR THE VENTILATOR BROKE. THERE WAS NO PATIENT INVOLVEMENT. (B)(4).
Additional Manufacturer Narrative
NO PARTS WERE RETURNED. INVESTIGATION WAS BASED ON PICTURES RECEIVED. ACCORDING TO THE PICTURES PROVIDED BY THE CUSTOMER, THE SUPPORT ARM BROKE AT THE JOINT NEAREST TO THE BRACKET. PRIOR INVESTIGATIONS OF SIMILAR BREAKAGES SHOWED THAT THE CAUSE FOR THE DAMAGE CAN BE ATTRIBUTED TO THE FOLLOWING: CRACKS / POROSITY IN THE CASTING PROCESS. OVERLOAD, USE OUTSIDE OF ITS SPECIFICATION. PREVIOUSLY PERFORMED INVESTIGATIONS HAVE LEAD TO A REDESIGN AND A CHANGE OF THE MANUFACTURING PROCESS IN ORDER TO OBTAIN A HIGHER MECHANICAL STRENGTH OF THE SUPPORT ARMS. THIS WAS IMPLEMENTED IN PRODUCTION DURING MAY 2009. HOWEVER, DESPITE THE ATTEMPTS TO OBTAIN PICTURES SHOWING THE MANUFACTURING DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. THEREFORE, THE ROOT CAUSE FOR THE BREAKAGE CANNOT BE ESTABLISHED FROM THIS INVESTIGATION.
Description of Event or Problem
(B)(4).