CARAT I pro and CARAT II pro Ventilators 에 대한 현장 안전성 서한
Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI)에 따르면, 해당 현장 안전성 서한 는
Slovenia
에서 HOFFRICHTER GmbH 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
During the boot-up of caratpro ventilators the software carries out an integrity check of the last used
settings and ventilation parameters. in case the alarm for “high frequency” was set to “off” the setting
is falsely recognized as corrupt. thereafter during the device restart the software’s security routine
restores the factory defaults instead of the previously used parameters for safety reasons. this takes
place without informing the user by technical notification or alarm. both, the false recognition of the
“high frequency” alarm setting and the absent information of the user, are part of a software bug. this
bug is present in all software versions up to and including version 2.003 and is corrected with software
version 2.004 and above. all devices with installed software version 2.004 are not affected by this
.