FLOWMETER
Received Jun 7, 2019 · Event occurred May 23, 2019
Report 9611500-2019-00168 · MDR key 8677498
Device
Generic name
Flowmeter, Gas
Manufacturer
Drägerwerk Ag & Co. KgaaModel number
NACatalog number
MP04560
Lot number
NA
Product problems
- Burst Container or Vessel
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION WAS CARRIED OUT BASED ON THE PROVIDED FLOWMETER. IT WAS FOUND THAT THE MATERIAL OF THE PRESSURE DOME IS TORN IN THE REGION OF THE THREAD WITH WHICH THE DOME IS SCREWED INTO THE BASE BODY OF THE FLOWMETER. THE CLEANING WIPES MICROBAC TISSUES USED ACCORDING TO THE CUSTOMER WORK ON THE BASIS OF QUATERNARY COMPOUNDS, WHICH ARE NOT RECOMMENDED BY DRÄGER AND ARE NOT COMPATIBLE WITH THE MATERIAL OF THE PRESSURE DOME (POLYCARBONATE) WHICH CAN LEAD TO STRESS CRACKS. ACCORDINGLY, THE REPORTED RUPTURE OF THE PRESSURE DOME CAN MOST LIKELY BE ATTRIBUTED TO STRESS CRACKS CAUSED BY THE USE OF INCOMPATIBLE CHEMICALS. STRESS CRACKING FINALLY RESULTING IN BURSTING IS NOT A SUDDEN EVENT, BUT A SLOW-MOVING PROCESS THAT CAN BE DETECTED IN TIME WITH REGULAR INSPECTION. THEREFORE THE IFU CONTAINS A WARNING THAT THE USER HAS TO CHECK THE PRESSURE DOME FOR CRACKS BEFORE USE. FURTHERMORE, THE PRESSURE DOME SHOULD BE CHECKED AT LEAST ONCE A YEAR BY TRAINED SPECIALIST PERSONNEL; IN DOING SO, THE PRESSURE DOME MUST BE UNSCREWED FROM THE FLOWMETER IN ORDER TO ALSO CHECK THE THREAD FOR ABNORMALITIES AND CRACKS.
Description of Event or Problem
PLEASE REFER TO THE INITIAL REPORT.
Additional Manufacturer Narrative
THE INVESTIGATION IS STILL ON-GOING. THE RESULTS WILL BE PROVIDED WITHIN A FOLLOW-UP REPORT.
Description of Event or Problem
IT WAS REPORTED THAT DURING THE USE OF THE FLOWMETER THE PRESSURE DOME EXPLODED. NO INJURY REPORTED.