AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL
Received Aug 9, 2017 · Event occurred Jul 17, 2017
Report 9610612-2017-00395 · MDR key 6778758
Device
Generic name
High Speed Power Systems
Manufacturer
Aesculap AgModel number
GA513RCatalog number
GA513R
Lot number
51981115
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Not reported
- Hearing Loss
- 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 DURING SURGERY. DUE TO THIS THERE WAS TEMPORARY HEARING LOSS BUT THE HEARING RETURNED AFTER A FEW HOURS.
Additional Manufacturer Narrative
INVESTIGATION: A DETAILED FAILURE ANALYSIS COULD NOT TAKE PLACE. THE HOSE BURST CENTRALLY. FUNCTIONALLY, THE MOTOR, THE AIR PLUG AS WELL AS THE HOSE ARE IN ORDER. A MECHANICAL DAMAGE CAN BE FOUND ON THE BURST HOSE. THE BRUISE MOST LIKELY CAUSED THE BURST OF THE AIRE HOSE. A CORRECT CIRCULATION OF THE EXHAUST AIR WAS NOT POSSIBLE. BATCH HISTORY REVIEW: THE DEVICE HISTORY FILES FOR THE MATERIAL HAS 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.