Regulators have reportedly issued a recall for a number of medical ventilators manufactured by Medtronic.
The company’s New Port HY70 and HT70 Plus ventilators are being recalled amidst concerns that the devices may suddenly shutdown or reset. There have so far been 12 reported cases whereby a reset was suddenly initiated without warning. Thankfully, no patients have yet suffered an injury!
The ventilators are typically found in hospitals, care homes and other healthcare facilities. They help patients with respiratory problems or breathing difficulties to breathe mechanically, and are commonly used during surgery when the patient is under general anaesthesia and is unable to safely control their own breathing as efficiently.
Patients with serious respiratory or lung conditions may also keep one of the respirators at home.
Reported software problem
Unfortunately, the fault that prompted the recall lies in the device’s software. The problem means that the ventilator can shut down at any time without warning, and when it shuts down, there are no visual or audible alerts to notify the patient or the health physician.
Without warning, the unexpected shut down may mean that not enough oxygen will be delivered to the patient. This could lead to a very high risk of hypoxia which can result in cases of stroke, carbon monoxide poisoning, heart problems, brain damage and even death. The device can be used by most patients, even infants as long as they weigh more than 11 pounds. Needless to say, the magnitude of harm hypoxia can cause in an infant can be significantly higher.
Numbers in the recall
Some 14,000 affected ventilators are set to be recalled worldwide. The affected units are product code “73-CBK“, manufactured between 4th March 2010 and 26th January 2017, and distributed between 4th March 2017 and 2nd Feb 2017.
Medtronic have issued an urgent advice as follows:
| Pay constant attention to the devices: keep checking them for any faults or sudden shutdowns. |
| Maintain alternate power sources and means of ventilation in case there is an unexpected shutdown. If there is an unexpected shutdown, the patient needs to be transferred to an alternative source of oxygen delivery immediately. |
| Monitor oxygen delivery for the patient by a trained physician – make sure they always have enough oxygen and ventilation by utilising a pulse oximeter and/ or a capnography |
| Link the machine to an alarm/nurse call so that staff are immediately notified of any unexpected shut downs. |
The manufacturer assures they’ve identified the source of the problem and will be implementing an update to resolve the issue. Medtronic notably have an extensive list of previous recalls, including for a number of other ventilators.
First published by Admin on August 23, 2017
Posted in the following categories: Medical Recalls and tagged with recalls