AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL

Additional Manufacturer Narrative

INVESTIGATION: THE DEVICE WAS DELIVERED ON THE 19TH OF JANUARY, 2011. A REPAIR TOOK PLACE ON THE 27TH OF SEPTEMBER, 2016. A DETAILED FAILURE ANALYSIS COULD NOT TAKE PLACE. THE HOSE BURST APPROXIMATELY 10 CM FROM THE MOTOR. FUNCTIONALLY, THE MOTOR, THE AIR PLUG AS WELL AS THE HOSE ARE IN ORDER. AT THE FRACTURED POSITIONS, NO MECHANICAL DAMAGES (BRUISES, CUTS) CAN BE FOUND. HOWEVER, FRAGMENTS ARE MISSING. A COMPLETE RECONSTRUCTION IS NOT POSSIBLE. MOST LIKELY, A CORRECT CIRCULATION OF THE EXHAUST AIR WAS NOT COMPLETELY POSSIBLE DURING USE, WHICH LED TO THE BURST OF THE HOSE. A LIMITATION OF THE EXHAUST AIR CAN OCCUR DUE TO A INCORRECT FIXATION OF THE HOSE OR DUE TO THE KINKING OF THE HOSE. BATCH HISTORY REVIEW; THE DEVICE HISTORY FILES FOR THE LOT NUMBER HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF A MAINTENANCE FAILURE. CONCLUSION AND ROOT CAUSE: ON THE BASIS OF THE CURRENT INVESTIGATION RESULTS, WE ASSUME THAT MOST LIKELY A HANDLING FAILURE LED TO THE DESCRIBED FAILURE PATTERN. HOWEVER, FURTHER INVESTIGATIONS WILL BE EXECUTED. NO CAPA IS NECESSARY.

Additional Manufacturer Narrative

EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

Description of Event or Problem

(B)(6). IT WAS REPORTED THAT DURING SURGERY THE AIR HOSE BURST. THE STAFF AND PATIENT EXPERIENCED HEARING TRAUMA.