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Recall Observatory FDA recall evidence

Device product

e700 Automatic Transport Ventilator, Model Number 01EVE700

Z-0978-2019

February 12, 2019

Class I

Product summary

Firm
O-Two Medical Technologies, Inc.
Event
Event 82178
Status
Terminated
Classification
Class I
Quantity
632
Official record key
device-enforcement:Z-0978-2019

Official wording

Reason: There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.

Code information: EV70001 to EV70658

Distribution pattern: The products were distributed to the following US states: AZ, CA, CO, FL, OH, PA, TX, and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for the unit to catch fire due to one of the screen retaining screws being incorrectly inserted. Due to this improper screw insertion the screw sat higher than normal allowing it to contact the underside of the main board causing the screw to rub against the bottom side of the board, wearing away the insulation layer and creating a short circuit.