International safety notice
A foreign manufacturer stated, ``We have confirmed one case in a foreign country where the ventilation operation of the product stopped and spontaneous breathing occurred during that time. As a result, it was determined that the cause was that the pressure regulator installed in the product did not operate properly.".
Japan / PMDA Recalls · JPN · Jul 28, 2021
Key facts
| Title | A foreign manufacturer stated, ``We have confirmed one case in a foreign country where the ventilation operation of the product stopped and spontaneous breathing occurred during that time. As a result, it was determined that the cause was that the pressure regulator installed in the product did not operate properly." . |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: General-purpose artificial respirator Brand name: NKV-550 series respirator |
| Manufacturer | Nihon Kohden Industries Co., Ltd. |
| Models | 00396, 00060, 00091, 00324, 00147, 00387, 00349, 00012, 00010, 00314, 00061, 00002 and 80 more |
| Date | Jul 28, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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