AIR HOSE 5.0M AESC.-DRAEGER/AESC.SMALL
Received May 30, 2018 · Event occurred May 2, 2018
Report 9610612-2018-00223 · MDR key 7553715
Device
Generic name
High Speed Power Systems
Manufacturer
Aesculap AgModel number
GA505RCatalog number
GA505R
Lot number
51960822
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: ACCORDING TO THE PROVIDED INFORMATION, IT CAME TO A BURST OF THE AIR HOSE DURING A SURGERY. THE SURGEON SUFFERED A TEMPORARY HEARING LOSS. DUE TO A LACK OF COMPONENTS, AN INVESTIGATION IS NOT POSSIBLE. THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR THE ABOVE MENTIONED LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. THE FAILURE IS MOST PROBABLY USER RELATED. A CAPA IS NO NECESSARY.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE HOSE BURSTED DURING THE OPERATION.