Set, Tubing And Support, Ventilator (W Harness)（BZO）

Ventilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test, which will result in "exhalation obstructed " alarm, which may result in inadequate ventilation, oxygen desaturation. Advising: Prior to use, test lung action. If alarm occurs, expiratory valve set removal to overcome membrane adhesion or replacement

IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't use in neonates/infants, with target tidal volumes less-than50mL or less-than10kg- at high risk of cardiopulmonary/neurological compromise due to unrecognized hypoventilation, updates for continued use in others before design update; leak may cause respiratory acidosis, hypoxemia, or respiratory failure.

Ventilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise inspiratory and expiratory flows, leading to partial or complete rebreathing of exhaled gases, which could lead to acute hypercapnia, respiratory acidosis, and if unrecognized organ dysfunction.

The potential for cracks forming in the breathing circuit hose.

Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

Updated labeling to ensure that blue cap on in-line valve is removed, prior to delivery of (Intrapulmonary percussive ventilation) IPV therapy.

The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Glued connections of the breathing circuit can become loose before or during ventilation resulting in partial or complete detachment of pieces.

Reports received of torn corrugated breathing tubes.

An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.

An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.

An issue has been discovered with the Hamilton Medical Infant Flow Sensor, single use. When a ventilation mode with adaptive volume control (APVcmv/CMV+) is used, the ventilator may adjust the ventilation on the inaccurate flow measurement and decrease the amount of ventilation delivered.

The Infant Nasal CPAP Prong has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted.

Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Dr¿ger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR. A

FPH has become aware that one batch of tubes supplied to FPH may contain hole damage. These tubes were incorporated by FPH into certain 900MR068 reusable circuits with lot numbers 110810 and 111020. If this hole damage is not detected during the standard leak test before patient use, it could potentially result in a gas leak in the breathing system, which may lead to a loss of pressure for the int