Ръководство за прилагане на системата за безопасност на медицинските изделия

Име на Националния Компетентен Орган (НКО)

Name of National Competent Authority (NCA)

Адрес на Националния Компетентен Орган

Address of National Competent Authority

Date of this report

Reference number assigned by the manufacturer

     

Reference number assigned by NCA to whom sent (if known)

     

All other reportable incidents

Identify to what other NCAs this report was also sent

 Производител / Manufacturer

 Упълномощен представител на територията на ЕИП и Швейцария

/Authorised Representative within EEA and Switzerland

 Други / Others: (определете ролята / identify the role)

Manufacturer name

     

Manufacturer’s contact person

     

Address

Postal code

     

City

Phone

Fax

     

Country ²⁾

     

Name of the Authorised Representative

     

The Authorised Representative’s contact person

     

Address

Postal code

City

Phone

Fax

Country ²⁾

Submitter’s name

     

Name of the contact person

     

Address

Postal code

City

Phone

Fax

Country ²⁾

 АИМИ Активни имплантати / AIMD Active implants

 МИ Клас III / MDD Class III  ИВДМИ Приложение I Списък А / IVD Annex II List A

 МИ Клас IIб /MDD Class IIb  ИВДМИ Приложение I Списък Б / IVD Annex II List B

 МИ Клас IIа /MDD Class IIa  ИВДМИ за самотестуване / IVD Devices for self-testing

 МИ Клас I /MDD Class I  ИВДМИ Други / IVD General

     

Nomenclature code

     

Nomenclature text

     

Commercial name/ brand name / make

     

Model and/or catalogue number

     

Serial number(s) and/or lot/batch number(s)

     

Software version number (if applicable)

     

Manufacturing date/ Expiry date, (if applicable)

     

Accessories/ associated device (if applicable)

     

Notified Body (NB) ID-number

     

User facility report reference number, if applicable

Manufacturers awareness date

Date the incident occurred

Incident description narrative

     

Number of patients involved (if known)

Number of medical devices involved (if known)

Medical device current location/disposition (if known)

 медицински специалист / health care professional

 пациент/ patient

 друг/ other

 първоначална употреба / initial use

 повторна употреба на медицински изделия за многократна употреба

/reuse of a reusable medical devices/

 повторна употреба на медицински изделия за еднократна употреба

/reuse of a single use medical device/

 след поправка/преработка / re-serviced/refurbished

 проблемът е установен преди употреба / problem noted prior use

 други / other (моля опишете/please specify)

Patient outcome

     

Remedial action taken by the healthcare facility relevant to the care of the patient

Age of the patient at the time of incident, if applicable

     

Gender, if applicable

 Женски / Female  Мъжки / Male

Weight in kilograms, if applicable

Name of the health care facility

Contact person within the facility

Address

Postcode

City

Phone

Fax

Country ²⁾

Manufacturer’s preliminary analysis

     

Initial corrective actions/preventive actions implemented by the manufacturer

     

Expected date of next report

     

The manufacturer’s device analysis results

     

Remedial action/ corrective action/ preventive action / Field Safety Corrective Action (FSCA)

     

Забележка: В случай на Коригиращи Действия, подателят трябва да попълни формата от Приложение 4 на Ръководство MEDDEV 2.12/1 rev 5/2007

NOTE: In the case of a FSCA the submitter needs to fill in the form of Annex 4 Medical Devices Vigilance System (MEDDEV 2.12/1 rev 5)

Time schedule for the implementation of the identified actions

Final comments from the manufacturer

     

Further investigations

     

Is the manufacturer aware of similar incidents with this type of medical device with a similar root cause?

If yes, state in which countries and the report reference numbers of the incidents.

     

For Final Report only: The medical device has been distributed to the following countries:

- в държавите от ЕИП и Швейцария / - within the EEA and Switzerland:

 AT  BE  BG  BU  CH  CY  CZ  DE  DK  EE  ES  FI  FR  GB

 GR  HU  IE  IS  IT  LI  LT  LU  LV  MT  NL  NO  PL  PT 

RO  SE  SI  SK

- Кандидат членки / Candidate Countries  CR  TR

 Във всички – ЕИП, Кандидат членки и Швейцария / ALL EEA , Candidate Countries and Switzerland

- други / others:

     

Име на Националния Компетентен Орган (НКО)

Name of National Competent Authority

Адрес на Националния Компетентен Орган

Address of National Competent Authority

Date of this report

Reference number assigned by the manufacturer

     

Incident reference number and name of the co-ordinating NCACompetent Authority (if applicable):

     

Identify to what other Competent Authorities this report was also sent

     

 Производител / Manufacturer

 Упълномощен представител в ЕИО / Authorised Representative within EEA

 Други / Others: (определете ролята / identify the role):      

Manufacturer name

     

Manufacturer’s contact person

     

Address

Postal code

     

City

Phone

Fax

     

Country ²⁾

     

Name of the Authorised Representative

     

The Authorised Representative’s contact person

     

Address

Postal code

City

Phone

Fax

Country ²⁾

National contact point name

     

Name of the contact person

     

Address

Postal code

City

Phone

Fax

Country ²⁾

 АИМИ Активни имплантати / AIMD Active implant

 МИ Клас III / MDD Class III  ИВДМИ Приложение I Списък А / IVD Annex II List A

 МИ Клас IIб /MDD Class IIb  ИВДМИ Приложение I Списък Б / IVD Annex II List B

 МИ Клас IIа /MDD Class IIa  ИВДМИ за самотестуване / IVD Devices for self-testing

 МИ Клас I / MDD Class I  ИВДМИ Други / IVD General

     

Nomenclature code

     

Nomenclature text

     

Commercial name/ brand name / make

     

Model number

     

Serial number(s) or lot/batch number(s)

     

Software version number (if applicable)

     

Manufacturing date/ Expiry date (if applicable)

     

Accessories/ associated device (if applicable)

     

Notified Body (NB) ID-number

     

Background information and reason for the FSCA,

     

Description and justification of the action (corrective/preventive)

     

Advice on actions to be taken by the distributor and the user.

     

Attached please find

 Съобщение на английски език  Съобщение на национален език

/Field Safety Notice (FSN) in English/ /FSN in national language/

 Други/ Others (please specify) …      

Time schedule for the implementation of the different actions

     

These countries within the EEA and Switzerland are affected by this FSCA:

- в държавите от ЕИП и Швейцария / - within the EEA and Switzerland:

 AT  BE  BG  BU  CH  CY  CZ  DE  DK  EE  ES  FI

 FR  GB  GR  HU  IE  IS  IT  LI  LT  LU  LV  MT

 NL  NO  PL  PT  RO  SE  SI  SK

- Кандидат членки / Candidate Countries  CR  TR

 Във всички – ЕИП, Кандидат членки и Швейцария / ALL EEA , Candidate Countries and Switzerland

- други / others:

These countries outside the EEA and Switzerland are affected by this FSCA: