Investigational product container number
Item
Investigational product container number
text
C0304229 (UMLS CUI [1,1])
C0180098 (UMLS CUI [1,2])
C0600091 (UMLS CUI [1,3])
Date of Device Malfunction
Item
Date of Device Malfunction
date
C1881681 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Time of Device Malfunction
Item
Time of Device Malfunction
time
C1881681 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
Item
Mark all applicable reasons for device malfunction
integer
C1881681 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
Code List
Mark all applicable reasons for device malfunction
CL Item
Mouthpiece Cover does not stay at the fully actuated position (1)
CL Item
Mouthpiece cover came apart rrom the mechanism (2)
CL Item
Inhaler is cracked or broken apart (3)
CL Item
Difficult to open mouthpiece cover/force to actuate was too high (4)
CL Item
Difficult to close mouthpiece cover (5)
CL Item
Powder fell out prior to use (6)
CL Item
No powder came out (7)
CL Item
Device squeaks In operation (8)
CL Item
Device rattles in operation (9)
CL Item
Dose counter did not count (10)
CL Item
Dose counter is ambiguous (11)
CL Item
Dose counter overcounted (12)
CL Item
Dose counter undercounted (13)
CL Item
Difficult to pull air through the device as described in the leaflet (14)
CL Item
Device smelt/bad odour when pack opened (15)
CL Item
Other, specify (16)
Device Malfunction reason
Item
Other Device Malfunction reason, specify
text
C1881681 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])