Ventilator, Emergency, Powered (Resuscitator)

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2025-01-10Open, ClassifiedProcess change control

  Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842

  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 PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

• 2024-10-02Open, ClassifiedProcess control

  Neo-Tee T-Piece Resuscitator. Part Numbers 1050805, 1050832. For pediatric emergency respiratory support.

  Manual resuscitator circuit flow controller may come apart due to a missing manufacturing step.

• 2024-09-20Open, ClassifiedOther

  paraPAC plus 310 ventilator kit with internal PEEP and CPAP, Item Number P310N

  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 active ventilation function.

• 2024-09-20Open, ClassifiedOther

  paraPAC 300 ventilator kit without internal PEEP and CPAP, Item Number P300N

  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 active ventilation function.

• 2024-09-11Open, ClassifiedUnder Investigation by firm

  Pneupac paraPAC plus 300 ventilator kit, REF P300NXX

  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.

• 2024-09-11Open, ClassifiedUnder Investigation by firm

  Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NXX

  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.

• 2024-03-19Open, ClassifiedUnder Investigation by firm

  smiths medical Pneupac paraPAC plus 310 ventilator kit with PEEP and CPAP, REF P310NUS

  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 cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.

• 2024-03-19Open, ClassifiedUnder Investigation by firm

  smiths medical Pneupac paraPAC plus 300 ventilator kit without PEEP and CPAP, REF P300NUS

  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 cycling like a human breath. This non-cycling and continuous positive gas flow when in the cycling mode, is a malfunction, not allowing the ventilator to properly function as designed.

• 2019-04-04TerminatedProcess control

  e500 Automatic Transport Ventilator, Model Number 01EVE500

  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.

• 2019-04-04TerminatedProcess control

  e600 Automatic Transport Ventilator, Model Number 01EVE600

  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.