AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL
Received Jul 20, 2017
Report 9610612-2017-00359 · MDR key 6728734
Device
Generic name
High Speed Power Systems
Manufacturer
Aesculap AgModel number
GA513RCatalog number
GA513R
Lot number
51931403
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 10TH OF JUNE 2013. A REPAIR OR A MAINTENANCE CANNOT BE FOUND IN THE SYSTEM. A FUNCTIONAL TESTING IS NOT POSSIBLE DUE TO THE FACT THAT THE HOSE AS WELL AS THE CONNECTIONS ARE TIGHT. ITS NOT POSSIBLE TO RECONSTRUCT THE HOSE AT THE BURST POSITION. FRAGMENTS ARE MISSING. A CLEAR AND DEFINITE CONCLUSION CAN NOT BE DRAWN. MOST LIKELY A HANDLING FAILURE (KINKING OF THE HOSE) LED TO THE MENTIONED BURST. 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.