FLOWMETER
Received Oct 10, 2022 · Event occurred Sep 15, 2022
Report 9611500-2022-00270 · MDR key 15572214
Device
Product problems
- Crack
- Fracture
- Gas/Air Leak
- Fracture
- Gas/Air Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PRESSURE DOME OF THE O2 FLOWMETER WAS CRACKED AT THE THREAD. NO INJURY REPORTED.
Additional Manufacturer Narrative
THE INVESTIGATION HAS JUST STARTED; RESULTS WILL BE PROVIDED IN A FOLLOW-UP REPORT.
Additional Manufacturer Narrative
IT WAS REPORTED THAT THE PRESSURE DOME OF A FLOW METER HAS CRACKED. THIS CAN BE CONFIRMED UPON VISUAL INSPECTION OF THE RETURNED ITEM. THE CUSTOMER REPORTEDLY DOES NOT USE REPROCESSING AGENTS CONTAINING ALCOHOL - HOWEVER, THE VISUAL APPEARANCE OF THE TENSION CRACKS MATCH EXACTLY WITH THOSE FROM PREVIOUSLY INVESTIGATED SIMILAR CASES DURING WHICH A CAUSAL CONNECTION TO REPROCESSING WITH INCOMPATIBLE CHEMICALS COULD CLEARLY BE ESTABLISHED. THIS CONFLICT IN INFORMATION COULD NOT BE REMOVED WITH IN THE FRAME OF THE ACTUAL COMPLAINT INVESTIGATION. THE PARTICULAR PRODUCT WAS MANUFACTURED IN 2018 WHEREBY A MATERIAL OR MANUFACTURING DEFECT CAN RATHER BE EXCLUDED. A RELIABLE CONCLUSION IN REGARD TO THE EXACT ROOT CAUSE CANNOT BE DRAWN.
Description of Event or Problem
IT WAS REPORTED THAT THE PRESSURE DOME OF THE O2 FLOWMETER WAS CRACKED AT THE THREAD. NO INJURY REPORTED.