AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL

Additional Manufacturer Narrative

AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

Description of Event or Problem

COUNTRY OF COMPLAINT: GERMANY. IT WAS REPORTED THAT A HOSE BURST LOUDLY. THE EMPLOYEES ARE AFFECTED WITH SUSPECTED ACUTE HEARING LOSS.

Additional Manufacturer Narrative

INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY ATS. SEVERAL CHAFE MARKS CAN BE FOUND AT PLUG AND THE OUTER HOSE. IMPACT MARKS ARE VISIBLE ON THE SOCKET AT THE MOTOR SIDE. A FUNCTION TEST COULD NOT BE CARRIED OUT. THE SURFACE OF THE INNER HOSE IS SOILED BY OIL AND WATER. NO LEAKAGES OF THE PLUG, THE SOCKET OR THE INNER HOSE COULD BE DETECTED. THE MAINTENANCE DATE (06.2016) WAS EXCEEDED BY APPROXIMATELY 5 MONTHS. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY USER RELATED. RATIONAL: MOST LIKELY THE BURST OF THE OUTER HOSE WAS CAUSED BY A MECHANICAL DAMAGE, FOR EXAMPLE A CUT, A STITCH OR A BRUISE. CORRECTIVE ACTION: ACCORDING TO SOP SA-DE13-M-4-2-01-010 A CAPA IS NOT NECESSARY.