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MDR > Annex > Flashcards

Annex Flashcards

1
Q

What umbrella of terms and codes does Annex B, C, and D fall under?

A

Annex B, C, and D fall under the “Cause Investigations” umbrella

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2
Q

What umbrella of terms and codes does Annex E & F fall under?

A

Health Effect

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3
Q

What terms and codes does Annex A contain?

A

Medical Device Problems terms and codes

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4
Q

What is the purpose of the terms and codes in Annex A?

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.

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5
Q

What terms and codes does Annex G contain?

A

Medical Device Parts and Components Terms and Codes

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6
Q

What is the purpose of the terms and codes in Annex G?

A

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.

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7
Q

What terms and codes does Annex B contain?

A

Annex B: Cause Investigation - Type of Investigation terms and codes

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8
Q

What is the purpose of the terms and codes in Annex B?

A

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.

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9
Q

What terms and codes does Annex C contain?

A

Annex C: Cause Investigation: Investigation Findings Terms and Codes

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10
Q

What is the purpose of the terms and codes in Annex C?

A

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).

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11
Q

What terms and codes does Annex D contain?

A

Annex D: Cause Investigation - Investigation Conclusion Terms and Codes

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12
Q

What is the purpose of the terms and codes in Annex D?

A

o These are terms and codes used for describing the conclusion of the investigation concerning the device involved in the reported adverse event.

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13
Q

What terms and codes does Annex E contain?

A

Annex E: Health Effect - Clinical Signs and Sympotms, and Conditions Terms and Codes

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14
Q

What is the purpose of the terms and codes in Annex E?

A

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.

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15
Q

What terms and codes does Annex F contain?

A

Health Effect - Health Impact Terms and Codes

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16
Q

What is the purpose of the terms and codes in Annex F? Give example of what kinds of consequences:

A

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.

17
Q

How is Annex G referred to in the 3500A form?

A

Medical Device Parts and Components terms and codes —> Component Code

18
Q

How is Annex E referred to in the 3500A form?

A

Health Effect - Clinical Signs and Symptoms, and Condition terms and codes —> Clinical Code

19
Q

How is Annex F referred to in the 3500A form?

A

Health Effect - Health Impact terms and codes —> Impact Code

20
Q

In what order do the annex codes appear in the 3500A form?

A
  1. Med.Device Parts&Components T/C AKA Component Code [Annex G]
  2. Health Effect - Clinical S/S, and conditions T/C AKA Clinical Code [Annex E]
  3. Health Effect - Health Impact T/C AKA Impact Code [Annex F]
  4. Medical Device Problems T/C [Annex A]
  5. Cause Investigation - Type of Investigation T/C [Annex B]
  6. Cause Investigation - Investigation Findings T/C [Annex C]
  7. Cause Investigation - Investigation Conclusion T/C [ Annex D]
21
Q

With Annex D terms and codes, what question should be answered?

A

What conclusion was formed regarding the root cause of the medical device induced adverse even/incident, as a result of the investigation?

MDR (8 decks)

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