Patient Monitors

Potential failure of the caster mounting hardware, which may result in the ventilator falling/tipping (overbalancing).

Potential delivery failure alarm condition. INOmax DSIR with software version 2.0.4 and a certain variant of the monitor display may trigger a delivery failure alarm when the display brightness is set to its lowest level. If this condition occurs, therapy will be interrupted.

A calibration problem was detected in a specific number of the Servo-I ventilator system CO2 analyzer models that may have been caused by the module's internal circuit board function.

Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.

An ECG procedure time stamp is incorrect, due to a software error in the McKesson Cardiology ECG Management with software versions 13.1 and 13.1.1.

Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor.

If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and short to ground. This may prevent the ventilator to switch to battery power if AC power is disrupted.

A software issue may lead to ventilator inoperative situations.

A failure of a specific component may prevent the ventilators from operating on AC power or transitioning back to AC power when operating on battery. Additionally, if a battery is not present or is depleted the ventilators will not operate. This failure will cause the loss of ventilator support, which may result in hypercarbia or hypoxemia.

CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ventilators due to misconnection by the operator. The input port on the ventilators must have the adapters correctly aligned to function properly. Incorrect alignment may cause the pins in the connector to bend, causing the PTV AC power adapter and/or PTV Auto Lighter Power Cord to be shortened, and pre

The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory compliance risk involving a material change. The changes to the gas pathway may potentially impact the safety of the device and quality of the gas condensates to the patient.

Philips IntelliSpace ECG (IECG) Management Systems that are importing Stress ECG records from a Quinton Stress ECG system have the potential for the patient record to contain multiple and therefore inaccurate patient identifiers such as: patient name, patient ID (PID), Medical record number (MRN). This creates the potential for misdiagnosis and incorrect therapy.

The temperature probe does not properly connect to the temperature port.

The temperature probe does not properly connect to the temperature port.

Spacelabs Healthcare is voluntarily recalling the Hamilton Galileo Ventilator Flexport, Model 90436A-07, where the monitored Minute Volumes (Vmin) has been reported at one time to reach ten times the actual value on the bedside monitor.

The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence.

The potentiometers (knobs) for setting the ventilation parameters may have contact interrupted and the device discontinues ventilation, gives an audible alarm and displays the error message Poti unplugged.

The battery capacity of the optional PS500 Power Supply Unit of the Infinity ACS Workstation Critical Care (Evita Infinity V500) did not last as long as expected.

Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.

Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly.