AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL
Received Oct 24, 2017
Report 9610612-2017-00534 · MDR key 6974567
Device
Generic name
High Speed Power Systems
Manufacturer
Aesculap AgModel number
GA513RCatalog number
GA513R
Lot number
51830335
Product problems
- Inflation Problem
- Inflation Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
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 TUBE BLOATED, BUT DID NOT BURST. ALL MED WATCH SUBMISSIONS RELATED TO THIS REPORT ARE: 9610612-2017-00535, 9610612-2017-00359, 9610612-2017-00383, 9610612-2017-00391.
Additional Manufacturer Narrative
A DETAILED FAILURE ANALYSIS COULD NOT TAKE PLACE. THE HOSE BURST APPROXIMATELY 10CM FROM THE MOTOR. FUNCTIONALLY, THE MOTOR, AIR PLUG AND 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 DEVICE HISTORY FILES FOR THE ABOVE MENTIONED LOT NUMBERS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. THERE IS NO INDICATION FOR A MANUFACTURING FAILURE. CONCLUSION AND ROOT CAUSE: THE MENTIONED FAILURE IS MOST LIKELY USER RELATED. NO CAPA IS NECESSARY.