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Pulmonary Ventilator Esprit V-100. Anvisa Registration No. 80102510035. Units at Risk: All Esprit V1000 manufactured before December 31, 2004 and Esprit V1000 manufactured prior to Dec 31, 2004 and converted to Esprit V200. 의 안전성 경고
Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 VR Medical Importadora e Distribuidora de Produtos Médicos Ltda.; Respironics Califórnia, Inc (Philips Respironics). 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
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사례 ID
1471
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날짜
2014-12-01
- 사례 국가
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사례 출처
ANVISA
- 사례 출처 URL
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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
The product manufacturer (Philips) has found that the fan hardware mounting screw of the Esprit V1000 and Esprit V200 fans may have been improperly installed, which may cause the end of the screw to touch the printed circuit board (PCBA) and cause a short circuit. This may prevent the ventilator from receiving battery power if the AC power (outlet) is interrupted. There is an auditory alarm on the equipment programmed to be triggered in a situation like this, alerting the medical staff about the loss of energy. Loss of energy in this situation may cause loss of the auxiliary ventilator, which could lead to hypercarbia or hypoxemia.
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원인
Incorrect mounting of the power supply fan screws can cause them to touch the pcba, causing a short circuit and consequently preventing the switch to the battery (dc) when necessary.
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조치
Field correction. The use of the equipment may be continued, but the user should pay attention to the following: (a) be alert for the occurrence of the emergency alarm, which should sound loud and alert that the equipment can not operate via battery; (b) ensuring that alternative forms of ventilation (resuscitator or similar apparatus) are available when the ventilator is in use in a patient; and (c) patients on life-support equipment should be visually monitored by the competent medical staff, as life-threatening conditions that do not trigger the alarm may occur. Follow the instructions in the Operator's Manual and always check life support equipment before using them.