o_two e700
O-Two Medical Technologies Inc · Model 01EVE700 · UDI-DI 07540195033016
Description
o_two e700 is electronically controlled, pneumatically powered ventilators with a AC/DC power adapter and an internal rechargeable Lithium Ion battery pack used to power the electronics, intended for use during transport to provide resuscitation and/or ventilatory support to wide range of patients in respiratory distress or arrest. It is a time-cycled, volume-constant and pressure-controlled emergency and transport ventilator designed for use in the pre-hospital, intra-hospital, inter-hospital and transport settings. It is intended for use with adult, child and infant patients with a tidal volume from 50 ml upwards who are in respiratory and/or cardiac arrest or respiratory distress who require ventilatory support.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-12-10 | Mercury Enterprises, Inc. dba Mercury Medical | Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and |
| 2024-08-30 | Mercury Enterprises, Inc. dba Mercury Medical | Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step. |
| 2024-05-31 | Smiths Medical ASD Inc. | Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the activ |
| 2024-05-31 | Smiths Medical ASD Inc. | There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. |
| 2024-05-31 | Smiths Medical ASD Inc. | Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the activ |
| 2024-05-31 | Smiths Medical ASD Inc. | There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings. |
| 2024-02-07 | Smiths Medical ASD Inc. | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cyclin |
| 2024-02-07 | Smiths Medical ASD Inc. | When a paraPAC plus ventilator is switched to the operating mode of VENTILATE, the ventilator may intermittently provide continuous positive gas flow instead of the intended cyclin |
| 2021-07-15 | Smiths Medical ASD Inc. | Two devices were labeled with the same serial number |
| 2020-06-26 | Precision Valve & Automation,Inc | While operating the machine in "Run" mode an unexcepted event may occur during the error-checking for stepper movements and pressure values. The result of this event is a false ala |
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