ALDUK IV

Additional Manufacturer Narrative

THE AFFECTED DEVICE WAS NOT AVAILABLE FOR THE INVESTIGATION; THE INVESTIGATION WAS BASED ON THE EVALUATION OF THE AVAILABLE INFORMATION. IN ADDITION, THE INVESTIGATION ALSO CONSIDERED INFORMATION FROM COMPARABLE CASES. BASED ON THE INVESTIGATION, THE REPORTED EVENT COULD BE CONFIRMED. IN COMPARABLE CASES WITH A SIMILAR FAILURE PATTERN, IT COULD ALREADY BE SHOWN THAT THE CAUSE WAS NOT DUE TO A DEVICE FAILURE. IF THE CYLINDER CONNECTION IS NOT COMPLETELY TIGHTENED BEFORE OPENING THE VALVE AND THE GAS ESCAPES THROUGH A LEAK, HEAT MAY BE GENERATED, AND THE O-RING MAY BE THERMALLY DAMAGED. THEREFORE, A USE ERROR MUST BE ASSUMED. THE OPERATING INSTRUCTIONS OF THE DEVICE CONTAIN A CORRESPONDING WARNING AND REMEDIAL MEASURES. ALL ALDUK SERIES HAVE PASSED THE NORMATIVE TEST FOR RESISTANCE TO BURNOUT WHEN EXPOSED TO OXYGEN PRESSURE SURGES ("BAM TEST") AND ARE APPROVED ACCORDING TO ISO 10524-1:2006. THE DIMENSIONS AND SIZES OF THE ALDUK CYLINDER CONNECTION IN THE VERSION FOR THE GERMAN MARKET COMPLY WITH THE APPLICABLE STANDARD DIN 477-1. THE NUMBER OF SIMILAR CASES, RELATED TO THE SAME ROOT CAUSE, IS WITHIN THE EXPECTED RANGE OF THE RESPECTIVE RISK ASSESSMENT AND THUS ACCEPTED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE THE DEVICE SELF-TEST THE USER OPENED THE O2 SUPPLY BOTTLE. IMMEDIATELY AFTERWARDS, A FLAME FORMATION WAS SEEN AT THE TRANSITION OF THE O2 SUPPLY BOTTLE TO THE ALDUK PRESSURE REDUCER. THERE WERE NO PATIENT NOR USER CONSEQUENCES REPORTED.