ALDUK IV
Received Aug 5, 2020 · Event occurred Jul 3, 2020
Report 9611500-2020-00271 · MDR key 10366988
Device
Product problems
- Use of Incorrect Control/Treatment Settings
- Overheating of Device
- Unexpected Therapeutic Results
- Device Handling Problem
- Use of Incorrect Control/Treatment Settings
- Overheating of Device
- Unexpected Therapeutic Results
- Device Handling Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE WAS AVAILABLE FOR THE INVESTIGATION; FURTHER AVAILABLE INFORMATION WAS ALSO CONSIDERED IN THE COURSE OF THE INVESTIGATION. BASED ON THE INVESTIGATION THE REPORTED EVENT COULD BE CONFIRMED. THE AFFECTED GAS CYLINDER CONNECTION OF THE ALDUK IV SHOWED TRACES OF SOOT AND THE REMAINS OF THE O-RING, INDICATING THAT HEAT HAD OCCURRED ON THE DEVICE. THE O-RING WAS REPLACED ON THE AFFECTED DEVICE AND THE DEVICE WAS TESTED ON AN O2 CYLINDER WITHOUT ANY ERROR PATTERN. THERE IS NO DEVICE FAULT AND THE ALDUK IV IS READY FOR USE AGAIN. 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
PLEASE REFER TO THE INITIAL-REPORT.
Additional Manufacturer Narrative
THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.
Description of Event or Problem
IT WAS REPORTED THAT AT THE BEGINNING OF THE DEVICE SELF-TEST ON AN OXYLOG3000 THE USER OPENED THE O2 SUPPLY BOTTLE. IMMEDIATELY AFTERWARDS, A FLASH WAS SEEN AT THE TRANSITION OF THE O2 SUPPLY BOTTLE TO THE ALDUK PRESSURE REDUCER. THERE WERE NO PATIENT NOR USER CONSEQUENCES REPORTED.