Events

Trade name: HeartStart; ANVISA registration numbers: 10216710136 and 10216710271; Risk class: III; Affected models: MRx and XL +; Affected series / lots: US00119303; US00119304; US00121905; US00121913; US00122596; US00122597; US00122710; US00122711; US00122712; US00122779; US00122780; US00122781; US00122782; US00122783; US00607333; US00607334; US00607335; US00607336; US00607337; US00607338; US00607339 and US00607340. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Philips Medical Systems Ltda. 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
    1860
  • 날짜
    2016-04-01
  • 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
    Philips will replace all affected sync cables with a new cable for free. A Philips Healthcare representative will contact customers with the affected devices to arrange replacement. If you find it difficult to follow the instructions contained in this release, please contact our Philips Solution Center at 0800-701-7789. Service from Monday to Saturday from 07h to 19h. #### UPDATED ON 7/18/2017, the company submitted completion report of the field action proving the accomplishment of exchange, as planned.
  • 원인
    When a philips monitor / defibrillator is receiving an ecg signal from an auxiliary bed monitor via sync cable, if the monitor / defibrillator is subject to interference from efts while connected to ac power, the following may occur: • in heartstart mrx and heartstart xl, eft noise can be misinterpreted as an r-wave. • in the heartstart xl +, eft noise can deactivate ecg monitoring and possibly stop the stimulus in demand mode *. * note: it is contrary to the xl + instructions for use (ifu) to perform the stimulus in demand mode while using the sync cable to deliver the ecg signal from a bed monitor. the xl + ifu includes the following warning: when stimulating in demand mode, the patient's ecg cable must be connected directly to the heartstart xl +. "if you follow this warning, this problem can not occur on xl +.
  • 조치
    Field Action Code: FCO86100165. Field Correction by Replacing the Affected Sync Cables ///// Recommendations to Users and Patients: Before receiving a replacement sync cable, you can continue to use the affected sync cables provided they are used only to connect the plug ECG output on the monitor / defibrillator to the (input) port of the ECG on a bed monitor. The problems described do not impact this application of the sync cable. The affected sync cables should not be used to connect the ECG output plug of a bed monitor to the ECG (input) port on the monitor / defibrillator.

Device

Trade name: HeartStart; ANVISA registration numbers: 10216710136 and 10216710271; Risk class: III...

Manufacturer

Philips Medical Systems Ltda.
  • 제조사 모회사 (2017)
    Philips
  • Source
    ANVSANVISA