AIR HOSE 5.0M AESC.-DRAEGER/AESC.LARGE
Received Oct 27, 2016
Report 2916714-2016-00936 · MDR key 6062021
Device
Generic name
High Speed Power Systems
Manufacturer
Aesculap AgModel number
GA466RCatalog number
GA466R
Lot number
51977098
Product problems
- Burst Container or Vessel
- Burst Container or Vessel
Patient
Not reported
- Injury
- Injury
Narrative
Additional Manufacturer Narrative
INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY THE AESCULAP TECHNICAL SERVICE DEPARTMENT (ATS). IT HAS BEEN ASCERTAINED, THAT AN OLD VERSION OF THE HOSE WAS USED. THIS HOSE WAS PRONE TO FLAWS WHICH COULD LEAD TO A BURST. THEREFORE THIS HOSE HAS BEEN CHANGED VIA THE INTERNAL CHANGE REQUEST: (B)(4). BATCH HISTORY REVIEW: THE DEVICE HISTORY FILES HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. CONCLUSION AND ROOT CAUSE: THIS FAILURE OCCURRED MOST LIKELY DUE TO DESIGN ERROR. CORRECTIVE ACTION: A CHANGE HAS BEEN INITIATED TO ELIMINATE THE FAILURE, SEE CHANGE. (B)(4).
Additional Manufacturer Narrative
(B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF (B)(4) (MANUFACTURER). EXEMPTION NUMBER: E2014018. G4. IT SHOULD BE NOTED THAT COMPLAINT INFORMATION WAS RECEIVED 07/07/2016; INFORMATION REGARDING BLAST INJURY WAS NOT RECEIVED UNTIL 10/24/2016. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: GERMANY. IT WAS REPORTED THAT 5 PEOPLE FROM THE OPERATION TEAM WERE INJURED WHEN THE AIR HOSE BURST.