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

Additional Manufacturer Narrative

BASED UPON REVIEW OF EVALUATION, THIS EVENT WAS RE-EVALUATED AND IS CONSIDERED NO LONGER REPORTABLE - NO MALFUNCTION OR SERIOUS INJURY. INVESTIGATION RESULTS: VISUAL INVESTIGATION: THE COMPLAINED PRODUCT GA513R WITH SERIAL NUMBER #(B)(6) HAS BEEN MANUFACTURED IN AUGUST 2018. THE LAST REPAIR/MAINTENANCE TOOK PLACE IN NOVEMBER 2019. VISUALLY, THE PRODUCT IS IN A HEAVILY USED CONDITION. IMPACT MARKS ON THE PLUG AND SCUFF MARKS ON THE HOUSING (WALL CONNECTION) ARE CLEARLY VISIBLE. FURTHERMORE, THE EXHAUST HOSE HAS COME LOOSE FROM ITS COMPRESSION FITTING. A FUNCTIONAL TEST COULD NOT BE CARRIED OUT. THE DAMAGE TO THE PLUG IS DUE TO FALLING AND IMPACT DAMAGE. THE EXACT CAUSE OF THE LOOSENING OF THE COMPRESSED AIR HOSE CANNOT BE DETERMINED. THE DAMAGE TO THE WALL CONNECTOR IS DEFINITELY DUE TO HANDLING. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBER AND WERE FOUND TO BE ACCORDING TO OUR SPECIFICATIONS VALID AT THE TIME OF PRODUCTION. REVIEW OF THE COMPLAINT HISTORY REVEALED THAT NO SIMILAR COMPLAINTS HAVE BEEN FILED AGAINST PRODUCTS FROM THIS BATCH NUMBER. THE REVIEW OF RISK ASSESSMENT REVEALED THAT THE OVERALL RISK LEVEL (SEVERITY 2(5) X PROBABILITY OF OCCURRENCE 1(5)) ACCORDING TO DIN EN ISO 14971 IS STILL ACCEPTABLE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. THE DAMAGE TO THE WALL CONNECTOR IS DEFINITELY DUE TO HANDLING. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH GA513R - AIR HOSE 3.0M AESC.-DRAEGER/AESC.SMALL. ACCORDING TO THE COMPLAINT DESCRIPTION, THE TUBE IMPLODED DURING THE SURGERY. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).