Description of Event or Problem · 0
ARMSTRONG MEDICAL LTD RECEIVED (B)(4); GE HEALTHCARE (B)(6) HAVE REPORTED AN ISSUE WITH (B)(6)-- LOT 010425F211. THE CUSTOMER REPORTED A LEAK >700ML, REPLACING THE DISPOSABLE LIME CONTAINER WITH A REUSABLE CONTAINER. THE PATIENT WAS NOT INJURED. REPLACEMENT OF THE LIME CONTAINER RESULTED IN THE REPORTED LEAK BEING REMOVED. NO LEAKS IN THE DEVICE IN MANUAL AND MECHANICAL VENTILATION MODES <100ML. REPORTS OF PATIENT INVOLVEMENT BUT NO PATIENT HARM. ARMSTRONG MEDICAL LTD CONSIDER THIS TO BE A REPORTABLE EVENT AS IT MEETS ALL THREE BASIC REPORTING CRITERIA A-C OF MEDDEV 2 12-1 REV.8 AND MDR ARTICLE 2 (65). THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM REPORTED. AS THIS PRODUCT IS AVAILABLE ON THE MARKET IN THE US, WE ARE OBLIGED TO REPORT TO FDA. PLEASE NOTE THAT DUE TO IT ISSUES WITH THE US PORTAL, ARMSTRONG MEDICAL LTD HAVE BEEN UNABLE TO SUBMIT REPORTS TO THE FDA UNTIL NOW.