International safety notice
As a result of a survey conducted by overseas manufacturers, all Trilogy Evo series models are equipped with software that calculates remaining battery power. Due to an issue with the hardware algorithm, one of the following events may occur even when sufficient power is provided: A problem has been identified. (1) When operating on battery power, there is a possibility that the treatment will stop, the power will be lost, and a beeping sound will be generated. (2) If connected to a permanent power source such as an AC power source or an external DC power source, the internal battery may become depleted while continuing treatment. ”Possibility of alarm occurring Please note that this issue may only occur if all of the following conditions are met: ・If the device is operating in CPAP or PSV mode ・If the device cannot detect the patient's breathing effort for at least 10 minutes and 55 seconds. The overseas manufacturer will provide information about the device to users and update the software. vinegar.
Japan / PMDA Recalls · JPN · Jun 24, 2024
Key facts
| Title | As a result of a survey conducted by overseas manufacturers, all Trilogy Evo series models are equipped with software that calculates remaining battery power. Due to an issue with the hardware algorithm, one of the following events may occur even when sufficient power is provided: A problem has been identified. (1) When operating on battery power, there is a possibility that the treatment will stop, the power will be lost, and a beeping sound will be generated. (2) If connected to a permanent power source such as an AC power source or an external DC power source, the internal battery may become depleted while continuing treatment. ”Possibility of alarm occurring Please note that this issue may only occur if all of the following conditions are met: ・If the device is operating in CPAP or PSV mode ・If the device cannot detect the patient's breathing effort for at least 10 minutes and 55 seconds. The overseas manufacturer will provide information about the device to users and update the software. vinegar. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Artificial respirator for adults Sales name: Trilogy Evo series |
| Manufacturer | Philips Japan Co., Ltd. |
| Models | H32565234D9C0, H31744385DC36, H321549862607, H352159314CDE, H291026352000, H35195064AF88, H31680061EE91, H3615646527F3, H2933080353A9, H36169368DF26, H293246313360, H352194199B6D and 14053 more |
| Date | Jun 24, 2024 |
| 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