Unomedical concentration oxygen mask recalled over dangerous defect

Unomedical concentration oxygen masks provide vital oxygen for patients. However, the Medicines and Healthcare products Regulatory Agency (MHRA) has found that a manufacturing fault could be disrupting supply, which could lead to oxygen deprivation for patients using the faulty oxygen masks.

This has led to an increased risk of Hypoxia (deficiency in the amount of oxygen reaching the tissues).

Manufacturer ConvaTec issued a voluntarily recall on 10^th May 2017 over concerns of health risks to patients. ConvaTec also distributes the affected oxygen masks to multiple countries in several European countries as well as Rwanda and Saudi Arabia, making this a far-reaching issue.

Risks to patients

Patients who do not get enough oxygen may experience various symptoms, including muscle and mental fatigue, nausea, dizziness and visual impairment. However, physicians and other healthcare providers may not always recognise these symptoms until it’s too late.

Prolonged oxygen deficiency can cause serious health problems, including:

In the most serious cases, a severe lack of oxygen can lead to a coma, and death.

Manufacturing fault

The manufacturing fault reportedly lies in the tube that connects the oxygen to the mask. The defect may result in the mask failing to deliver much-needed oxygen to patients using the device.

The recall states:

“…an internal assessment of product reports has confirmed that these devices are not meeting our expectations or those of our customers. In some cases, the tubing has been found to disconnect from the oxygen mask, prior to or during use, causing a disruption in supply of oxygen.”

Instructions for the recall

37 lots across 8 different products are thought to be affected by the recall. Hospitals, healthcare centres and other health institutions who stock and use the masks are urged to check if they have any faulty devices. Once identified, ConvaTec provides instructions to:

The hassle in recalling the affected units may impact the quality of care provided by hospitals. This is why medical device manufacturers should always ensure their products are absolutely safe for use through rigorous testing before and after releasing them into the market.

The important responsibility of medical device manufacturers

Manufacturers of medical health products have an important responsibility to their consumers. As their devices are designed to be used for treating vulnerable people, even a small fault could be the difference between life and death for a patient.

In this case, an absence of controlled oxygen for someone who (as an example) is short of breath having been rescued from a house fire may suffer a lack of the clean oxygen their lungs desperately need. If a defect with the device is starving the patient of lifesaving air, the consequences really can be severe.

If you have been harmed because of a faulty medical product, you may be eligible to recover financial compensation. Medical device manufacturers have a duty to provide safe-for-use products and inform their consumers (e.g. hospitals) of any risks so that they may in turn warn the patient.