Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는
Brazil
에서 WHEELCHAIRS OF KANSAS 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.
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
UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
원인
An ecri member hospital reported two incidents in which the accession of the bariatric rehabilitation platform is released, causing injury to the nurse. the course of the launder was still under the nurse that has not being adjusting the equipment that holds handling.
조치
MAKE SURE THAT TEAM MEMBERS ARE TRAINED ABOUT THE CORRECT USE OF THE BED SHEET MECHANISM. REPORT TO EMPLOYEES THAT HANDLING CAN FALL IF IT IS NOT TIGHT WELL. (2) MAKE SURE THAT EMPLOYEES ROTINALLY CHECK THE MECHANISM OF THE LAYOUT OF THE BED TO MAKE SURE THAT THE SAME IS SECURELY ADAPTED / TIGHTENED, AS WELL AS THE OTHER MECHANISMS OF THE BED. (3) ENSURE EMPLOYEES NOT TO DRIVE OR MOVE BRUSHLY AGAINST COURT BURNING TO PREVENT NON-INTENTIONAL LOOSENING. (4) IF THERE ARE ANY SUSPICIOUS PROBLEMS WITH THE BED, PLEASE CONTACT YOUR LOCAL DISTRIBUTOR OR DIRECTLY WITH WHEELCHAIRS OF KANSAS