Annex Flashcards
What umbrella of terms and codes does Annex B, C, and D fall under?
Annex B, C, and D fall under the “Cause Investigations” umbrella
What umbrella of terms and codes does Annex E & F fall under?
Health Effect
What terms and codes does Annex A contain?
Medical Device Problems terms and codes
What is the purpose of the terms and codes in Annex A?
The purpose of the terms and codes of Annex A is to capture/describe medical device problems (malfunction, deterioration of function, failure) that have occurred in both pre- or post- market contexts (e.g.: clinical studies, clinical evaluation, or post-market vigilance) through observational language without attaching possible reasons or causes for those observed problems or failures.
What terms and codes does Annex G contain?
Medical Device Parts and Components Terms and Codes
What is the purpose of the terms and codes in Annex G?
The terms and codes of Annex G serve to describe and capture the specific part or component involved in or affected by the medical device induced adverse event/incident.
What terms and codes does Annex B contain?
Annex B: Cause Investigation - Type of Investigation terms and codes
What is the purpose of the terms and codes in Annex B?
The terms and codes of Annex B serve to describe what was investigated and what kind of investigation was conducted to identify the root cause of the adverse event.
What terms and codes does Annex C contain?
Annex C: Cause Investigation: Investigation Findings Terms and Codes
What is the purpose of the terms and codes in Annex C?
The terms and codes of Annex C describe the findings/results, which are the keys to identifying the root cause of the adverse event that were gathered from the aforementioned specific type of investigation (with the use of Annex B in the space provided).
What terms and codes does Annex D contain?
Annex D: Cause Investigation - Investigation Conclusion Terms and Codes
What is the purpose of the terms and codes in Annex D?
o These are terms and codes used for describing the conclusion of the investigation concerning the device involved in the reported adverse event.
What terms and codes does Annex E contain?
Annex E: Health Effect - Clinical Signs and Sympotms, and Conditions Terms and Codes
What is the purpose of the terms and codes in Annex E?
o These terms and codes allow for the capturing/describing of the clinical signs and symptoms, and/or conditions of the affected person (PT) appearing as a result of the medical device induced adverse event/incident through observational language without using diagnostic specifics.
What terms and codes does Annex F contain?
Health Effect - Health Impact Terms and Codes
What is the purpose of the terms and codes in Annex F? Give example of what kinds of consequences:
The terms and codes of Annex F describe the resulting consequences that the medical device induced adverce event/incident had on the affected person (PT)
These consequences can include PT outcomes, and interventions or procedures used to treat the adverse event.
How is Annex G referred to in the 3500A form?
Medical Device Parts and Components terms and codes —> Component Code
How is Annex E referred to in the 3500A form?
Health Effect - Clinical Signs and Symptoms, and Condition terms and codes —> Clinical Code
How is Annex F referred to in the 3500A form?
Health Effect - Health Impact terms and codes —> Impact Code
In what order do the annex codes appear in the 3500A form?
- Med.Device Parts&Components T/C AKA Component Code [Annex G]
- Health Effect - Clinical S/S, and conditions T/C AKA Clinical Code [Annex E]
- Health Effect - Health Impact T/C AKA Impact Code [Annex F]
- Medical Device Problems T/C [Annex A]
- Cause Investigation - Type of Investigation T/C [Annex B]
- Cause Investigation - Investigation Findings T/C [Annex C]
- Cause Investigation - Investigation Conclusion T/C [ Annex D]
With Annex D terms and codes, what question should be answered?
What conclusion was formed regarding the root cause of the medical device induced adverse even/incident, as a result of the investigation?
