ALDUK IV

Additional Manufacturer Narrative

THE INVESTIGATION WAS BASED ON THE ANALYSIS OF THE AVAILABLE INFORMATION. IN ADDITION, THE INVESTIGATION ALSO TOOK INTO ACCOUNT INFORMATION FROM SIMILAR CASES. BASED ON THE INVESTIGATION, THE REPORTED EVENT COULD BE TRACED. IN SIMILAR CASES WITH A COMPARABLE ERROR PATTERN, IT COULD ALREADY BE SHOWN THAT THE CAUSE WAS NOT DUE TO A DEVICE ERROR. THE CONNECTION IS SAFE WHEN HANDLED CORRECTLY, AS LONG AS IT IS PROPERLY TIGHTENED TO PREVENT OXYGEN FROM ESCAPING. IF THE CYLINDER CONNECTION IS NOT COMPLETELY TIGHTENED BEFORE THE VALVE IS OPENED AND THE GAS ESCAPES THROUGH A LEAK, HEAT MAY BE GENERATED AND THE O-RING MAY BE THERMALLY DAMAGED. AN APPLICATION ERROR MUST THEREFORE BE ASSUMED. THE INSTRUCTIONS FOR USE OF THE DEVICE CONTAIN A CORRESPONDING WARNING AND CORRECTIVE MEASURES. ALL ALDUK SERIES HAVE PASSED THE NORMATIVE TEST FOR BURNOUT RESISTANCE WHEN EXPOSED TO OXYGEN PRESSURE SURGES ("BAM TEST") AND ARE APPROVED ACCORDING TO ISO 10524-1:2006. THE DIMENSIONS AND MEASUREMENTS OF THE ALDUK CYLINDER CONNECTION IN THE VERSION FOR THE (B)(4) MARKET CORRESPOND TO THE VALID STANDARD DIN 477-1. THE NUMBER OF COMPARABLE CASES, RELATED TO THE ROOT CAUSE, IS WITHIN THE RANGE INITIALLY ASSUMED IN THE UNDERLYING RISK ASSESSMENT AND IS THUS ACCEPTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A TRAINING OF A NEW EMPLOYEE (NURSING) IN THE OXYLOG DEVICE. THE CHANGING OF THE OXYGEN CYLINDER WAS FIRST EXPLAINED AND DEMONSTRATED THEORETICALLY, THEN PRACTICALLY. DURING THE REPEATED CHANGE BY THE PERSON BEING TRAINED, A CLEAR LEAK WAS HEARD, WHEREUPON THE USER IMMEDIATELY WANTED TO CLOSE THE O2 CYLINDER. AT THE SAME TIME THERE WAS A SPARK AND STRONG HEATING OF THE PRESSURE REDUCER (OXYLINE). THE BOTTLE COULD NEVERTHELESS BE CAPPED, BUT THE SEAL WAS THEN THE CYLINDER COULD NEVERTHELESS BE CLOSED, BUT THERE WAS CONSIDERABLE CHARRING OF THE SEAL ON THE PRESSURE REDUCER AND ON THE THREAD OF THE OXYGEN CYLINDER. NO INJURY WAS REPORTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A TRAINING OF A NEW EMPLOYEE (NURSING) IN THE OXYLOG DEVICE. THE CHANGING OF THE OXYGEN CYLINDER WAS FIRST EXPLAINED AND DEMONSTRATED THEORETICALLY, THEN PRACTICALLY. DURING THE REPEATED CHANGE BY THE PERSON BEING TRAINED, A CLEAR LEAK WAS HEARD, WHEREUPON THE USER IMMEDIATELY WANTED TO CLOSE THE O2 CYLINDER. AT THE SAME TIME THERE WAS A SPARK AND STRONG HEATING OF THE PRESSURE REDUCER (OXYLINE). THE BOTTLE COULD NEVERTHELESS BE CAPPED, BUT THE SEAL WAS THEN THE CYLINDER COULD NEVERTHELESS BE CLOSED, BUT THERE WAS CONSIDERABLE CHARRING OF THE SEAL ON THE PRESSURE REDUCER AND ON THE THREAD OF THE OXYGEN CYLINDER. NO INJURY WAS REPORTED.

Additional Manufacturer Narrative

DUE TO A TECHNICAL ISSUE WITH OUR INTERNAL EMDR SYSTEM WE SUBMITTED FOR THE FORM FDA 3500A AN INCORRECT VALUE FOR THE FIELD. NOT RETURNED TO MANUFACTURER.

Additional Manufacturer Narrative

THE INVESTIGATION WAS BASED ON THE ANALYSIS OF THE AVAILABLE INFORMATION. IN ADDITION, THE INVESTIGATION ALSO TOOK INTO ACCOUNT INFORMATION FROM SIMILAR CASES. BASED ON THE INVESTIGATION, THE REPORTED EVENT COULD BE TRACED. IN SIMILAR CASES WITH A COMPARABLE ERROR PATTERN, IT COULD ALREADY BE SHOWN THAT THE CAUSE WAS NOT DUE TO A DEVICE ERROR. THE CONNECTION IS SAFE WHEN HANDLED CORRECTLY, AS LONG AS IT IS PROPERLY TIGHTENED TO PREVENT OXYGEN FROM ESCAPING. IF THE CYLINDER CONNECTION IS NOT COMPLETELY TIGHTENED BEFORE THE VALVE IS OPENED AND THE GAS ESCAPES THROUGH A LEAK, HEAT MAY BE GENERATED AND THE O-RING MAY BE THERMALLY DAMAGED. AN APPLICATION ERROR MUST THEREFORE BE ASSUMED. THE INSTRUCTIONS FOR USE OF THE DEVICE CONTAIN A CORRESPONDING WARNING AND CORRECTIVE MEASURES. ALL ALDUK SERIES HAVE PASSED THE NORMATIVE TEST FOR BURNOUT RESISTANCE WHEN EXPOSED TO OXYGEN PRESSURE SURGES ("BAM TEST") AND ARE APPROVED ACCORDING TO ISO 10524-1:2006. THE DIMENSIONS AND MEASUREMENTS OF THE ALDUK CYLINDER CONNECTION IN THE VERSION FOR THE (B)(4) MARKET CORRESPOND TO THE VALID STANDARD DIN 477-1. THE NUMBER OF COMPARABLE CASES, RELATED TO THE ROOT CAUSE, IS WITHIN THE RANGE INITIALLY ASSUMED IN THE UNDERLYING RISK ASSESSMENT AND IS THUS ACCEPTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A TRAINING OF A NEW EMPLOYEE (NURSING) IN THE OXYLOG DEVICE. THE CHANGING OF THE OXYGEN CYLINDER WAS FIRST EXPLAINED AND DEMONSTRATED THEORETICALLY, THEN PRACTICALLY. DURING THE REPEATED CHANGE BY THE PERSON BEING TRAINED, A CLEAR LEAK WAS HEARD, WHEREUPON THE USER IMMEDIATELY WANTED TO CLOSE THE O2 CYLINDER. AT THE SAME TIME THERE WAS A SPARK AND STRONG HEATING OF THE PRESSURE REDUCER (OXYLINE). THE BOTTLE COULD NEVERTHELESS BE CAPPED, BUT THE SEAL WAS THEN THE CYLINDER COULD NEVERTHELESS BE CLOSED, BUT THERE WAS CONSIDERABLE CHARRING OF THE SEAL ON THE PRESSURE REDUCER AND ON THE THREAD OF THE OXYGEN CYLINDER. NO INJURY WAS REPORTED.