AIR HOSE 5.0M SCHRADER/AESCULAP SMALL
Received Aug 9, 2017 · Event occurred Jul 20, 2017
Report 9610612-2017-00413 · MDR key 6778798
Device
Generic name
High Speed Power Systems
Manufacturer
Aesculap AgModel number
GA506RCatalog number
GA506R
Lot number
52008050
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
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
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE AIR HOSE BURST.
Additional Manufacturer Narrative
INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY THE AESCULAP TECHNICAL SERVICE DEPARTMENT (ATS). THE DEVICE WAS DELIVERED ON THE 28TH OF JANUARY 2014. MAINTENANCE DID NOT TAKE PLACE IN (B)(4), BUT PROBABLY AT ATS (B)(4), DUE TO THE MAINTENANCE DATE OF AUGUST 2017, WHICH CAN BE FOUND ON THE HOSE. A DETAILED FAILURE COULD NOT TAKE PLACE. THE HOSE BURST APPROXIMATELY 10CM FROM THE MOTOR. FUNCTIONALLY, THE MOTOR, THE AIR PLUG, AND THE HOSE ARE FINE. AT THE FRACTURED POSITIONS, 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 A KINKING OF THE HOSE. BATCH HISTORY REVIEW: THE DEVICE HISTORY FILES FOR THE ABOVE MENTIONED LOT NUMBER 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: ON THE BASIS OF THE CURRENT INVESTIGATION RESULTS, WE ASSUME THAT MOST LIKELY A HANDLING FAILURE LED TO THE DESCRIBED FAILURE PATTERN. NO CAPA IS NECESSARY.