SUPPORT ARM 176

Description of Event or Problem

IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. THERE WAS NO PATIENT HARM REPORTED. MANUFACTURER'S REF. #:(B)(4).

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE VENTILATOR'S SUPPORT ARM WAS BROKEN. NO PATIENT INVOLVED. THE REPORTED ISSUE WITH BROKEN PARTS WAS CONFIRMED IN PROBLEM DESCRIPTION AND ADDITIONAL INFORMATION, WHERE IT WAS STATED THAT THE SUPPORT ARM BROKE AT PROXIMAL END (RAIL CLAMP). OUR FIELD SERVICE ENGINEER (FSE) INSPECTED THE VENTILATOR ON SITE AND SOLVED THE ISSUE BY REPLACING THE BROKEN PARTS. THE ROOT CAUSE HAS NOT BEEN CONCLUSIVELY DETERMINED. HOWEVER, THE BREAKING POINT INDICATES THAT IT MOST LIKELY HAS BEEN EXPOSED TO A MECHANICAL FORCE GREATER THAN IT IS DESIGNED TO SUSTAIN. THE BROKEN SUPPORT ARM WAS NOT RETURNED TO US FOR FURTHER INVESTIGATION. THE MANUFACTURING DATE IS UNKNOWN HOWEVER 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.

Description of Event or Problem

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