International safety notice
An alarm is issued when one of the two processors that monitors each other goes into forced shutdown during ventilation operation. An exceptional event in which ventilation stopped without any warning was discovered during an in-house bench test at an overseas manufacturer, and a firmware countermeasure was developed. Since April 12, 2022, we have carried out a recall for upgrading to We have issued a new warning and confirmed several cases where ventilation stopped. Investigation revealed that this issue was a combination of hardware and firmware issues, and primarily occurred when charging the removable battery. I found out what you're doing. It turns out that there are times when the ventilation stops, resulting in a forced shutdown. Due to a shortage of supply of signal buffers on circuit boards, substitute parts were temporarily adopted, but the substitute parts had noise It has also been confirmed that failures caused by these parts occur at a higher rate than with genuine parts. To address this issue, firmware upgrades are available to minimize the effects of noise interference on the communication bus. do the following.
Japan / PMDA Recalls · JPN · Jan 20, 2023
Key facts
| Title | An alarm is issued when one of the two processors that monitors each other goes into forced shutdown during ventilation operation. An exceptional event in which ventilation stopped without any warning was discovered during an in-house bench test at an overseas manufacturer, and a firmware countermeasure was developed. Since April 12, 2022, we have carried out a recall for upgrading to We have issued a new warning and confirmed several cases where ventilation stopped. Investigation revealed that this issue was a combination of hardware and firmware issues, and primarily occurred when charging the removable battery. I found out what you're doing. It turns out that there are times when the ventilation stops, resulting in a forced shutdown. Due to a shortage of supply of signal buffers on circuit boards, substitute parts were temporarily adopted, but the substitute parts had noise It has also been confirmed that failures caused by these parts occur at a higher rate than with genuine parts. To address this issue, firmware upgrades are available to minimize the effects of noise interference on the communication bus. do the following. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: General-purpose artificial respirator Sales name: (1) Smart ventilator Vivo 45 (2) Smart ventilator Vivo 45LS |
| Manufacturer | Chest Co., Ltd. |
| Models | M160071, D510256, M290517, M060191, M220174, D360727, M240490, M160393, K490381, M200058, D260238, D020020 and 3065 more |
| Date | Jan 20, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 10–99 Matching catalog numbers in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1