AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL
Received Jul 25, 2017
Report 9610612-2017-00391 · MDR key 6742349
Device
Generic name
High Speed Power Systems
Manufacturer
Aesculap AgModel number
GA513RCatalog number
GA513R
Lot number
51733751
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Not reported
- Deafness
- Hearing Loss
- Deafness
- Hearing Loss
Narrative
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE AIR HOSE BURST AND THE OPERATING ROOM STAFF EXPERIENCED A FEW HOURS OR TWENTY FOUR HOURS OF TEMPORARY HEARING LOSS.
Additional Manufacturer Narrative
INVESTIGATION: THE DEVICE WAS DELIVERED ON THE 7TH OF APRIL, 2011. A REPAIR TOOK PLACE ON THE 29TH OF DECEMBER, 2016. A DETAILED FAILURE ANALYSIS COULD NOT TAKE PLACE. THE HOSE BURST APPROXIMATELY 10CM FROM THE MOTOR. FUNCTIONALLY, THE MOTOR, THE AIR PLUG AS WELL AS THE HOSE ARE IN ORDER. AT THE FRACTURE PLACES, 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 AN 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 SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION FOR A MANUFACTURING FAILURE. CONCLUSION AND ROOT CAUSE: THE MENTIONED FAILURE IS MOST PROBABLY USER RELATED. NO CAPA IS NECESSARY.