Events

Mortara Digital Holter Recorder /// ANVISA Record Number: 80288099012 /// Hazard Class: II /// Model: H3 + (Plus - CHEXXXXX) /// Lots: 115190255741/115190255742/115190255743/115190255744/115190255744/115190255746 / 115190255759/115190255760/115190255761/115190255763/115190255764/115190255767/115190255769/115190255770/115190255773/115190255777/115190255778/115190255779/115190255780/115190255787/115190255788/115190255789/115190255786/115190255800/115190255803/115190255804/115190255808/115190255809/115190255810/115190255814/115190255822 / 115190255823/115190255824/115190255826/115190255827/115190255830/115190255832/115190255833/115190255834/115190255835/115260261298/115260261299/115260261300/115260261301/115260261302/115260261303/115260261304/115260261305/115260261306/115260261307/115260261308/115260261309/115260261310/115260261311/115260261312/115260261313 / 115260261314/115260261315/115260261316/115260261317/115260261318/11 52602613119/15260261320/115260261321/115260261322/115260261323/115260261324/115260261325/115260261326/115260261327/115260261328/115260261329/115260261330/115260261331/115260261332/115260261333/115260261334/115260261335/115260261336/115260261337/115260261338/115260261339/115260261340/115260261341/115260261342/115260261343 / 115260261344/115260261346/115260261348/115260261349/115260261350/115260261351/115260261351/115260261352/115260261353/115260261354/115260261355 115260261356/115260261357. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 TKL Importação e Exportação de Produtos Médicos e Hospitalares Ltda; Mortara Instrument Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1862
  • 날짜
    2016-04-08
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
  • 원인
    According to tkl, "we received a field corrective action notice from the manufacturer" field corrective action notice "on 11/19/2015, reporting that it identified a problem with the hardware of the h3 + model equipment, which could result in a battery current higher than normal and cause the device to record less time than expected, requiring corrective repair of the equipment hardware. ".
  • 조치
    The action is being taken due to the identification of a problem in the hardware of the H3 + model, which can result in a higher than normal battery current and cause the device to record less time than expected, requiring corrective repair action device hardware. a) Risk classification III; b) Classification of the field action: Correction in Field / Correction of parts and pieces / Other situation (IncisoIV); c) Field action code: 001.16; d) recommendations to users and patients: Segregate product for service repair.

Device

Mortara Digital Holter Recorder /// ANVISA Record Number: 80288099012 /// Hazard Class: II /// Mo...

Manufacturer

TKL Importação e Exportação de Produtos Médicos e Hospitalares Ltda; Mortara Instrument Inc.
  • Source
    ANVSANVISA