Table 7 Differences between the definition in medical device problem and in patient problem

損傷 (damage/injury)

(medical device problem) Break

(patient problem) Injury

汚染 (contamination)

(medical device problem): Contamination of device

(patient problem): Contamination of patient

発熱 (fever)

(medical device problem) generation of heat from a device or its component

(patient problem) Fever

感染 (infection)

(medical device problem) An aseptic condition cannot be maintained due to broken packaging, etc. Exists in the category term

(patient problem) Bacteria invade the human body

感電 (electrification)

(medical device problem/patient problem) get an electric shock

その他の事象 (other events)

(medical device problem/patient problem) This term exists as a category term and preferred terms which are not allocated in other category terms are involved

その他 (Others)

(medical device problem) There was only one combination of the category term “Others” and the preferred name “Others”. It was defined as “an unknown medical device problem.”

(patient problem) Below the category term “others,” three preferred names exist: “others,” “unknown,” and “no patient problems.”

不明 (unknown)

(medical device problem) cause unknown

(patient problem) cause unknown and no information