Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 Drägerwerk AG & Co. KGaA 에 의해 제조된 제품과 관련되어 있습니다.
이것은 무엇인가요?
현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 recall data from the U.S. and Slovenia.
데이터 추가 비고
원인
In december 2015, we notified you of an error we noticed in the market for oxylog 3000 family products, where the loss of contact of one of the control buttons triggers an error message (formerly known as a "potentiometer off"). in these cases, acoustic and optical signals are triggered and the respiratory release pressure and ventilation function are interrupted. no injuries were reported in any of these cases. our investigations have shown that fault conditions are triggered by the oxide layer in the potentiometer. oxide layers can form over time when several factors are present, e.G. if you rarely move the buttons or not at all. the proven solution is repeated knob rotation to remove the oxide layer. this recommendation was described in a previous safety notice.