AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL
Received Jul 20, 2017
Report 9610612-2017-00383 · MDR key 6728750
Device
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Not reported
- Hearing Loss
- Hearing Loss
Narrative
Additional Manufacturer Narrative
INVESTIGATION: THE DEVICE WAS DELIVERED ON THE 19TH OF DECEMBER 2015. A REPAIR TOOK PLACE ON THE 9TH OF DECEMBER 2016. A DETAILED FAILURE ANALYSIS COULD NOT TAKE PLACE. THE HOSE BUSTED APPROXIMATELY 10CM 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. THE HOSE IS GREASY/OILY. 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 AN INCORRECT FIXATION OF THE HOSE OR DUE TO A KINKING OF THE HOSE. BATCH HISTORY REVIEW: THE DEVICE HISTORY FILES HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION OF A MANUFACTURING FAILURE. CONCLUSION AND ROOT CAUSE: THE MENTIONED FAILURE IS MOST PROBABLY USER RELATED. NO CAPA IS NECESSARY.
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). DURING SURGERY IT WAS REPORTED THAT THE AIR HOSE BURST. TWO (2) SURGICAL NURSES HAD TEMPORARY DEAFNESS. AFTER A FEW HOURS THEIR HEARING RETURNED.