Li-Ion Battery used with the Maquet CARDIOSAVE Hybrid IABP and Maquet CARDIOSAVE Rescue IABP 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 Maquet 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.
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Maquet continually monitors the performance of the cardiosave iabps and has discovered an issue that
could affect the li-ion battery used with the cardiosave iabp. if the li-ion battery is accidently dropped,
the impact may cause the battery to vent. in addition to the risks contained in the warnings section of the
operator/user instructions, battery venting has the potential to create smoke, a foul odor, and sparks.
it is important to note that to date, there has been no reported patient harm or adverse events attributable to this
issue. of the more than 8,000 li-ion batteries distributed worldwide, to date, there have been 3 reported
occurrences of the battery venting when dropped. .