A reported manufacturing fault of a medical device has caused a great deal of concern within the healthcare industry. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a field safety notice to notify healthcare providers and users alike.
Due to a reported manufacturing fault, the Bag-Valve-Mask (BVM) manual resuscitation system could cause injury or even death as the valve may become stuck during storage, possibly resulting in the intended airflow not being delivered. Consequently, there may be a delay in the treatment.
What is a BVM?
A BVM, manufactured by Intersurgical, is used in an emergency situation to provide positive pressure ventilation to patients who are not breathing or having trouble breathing.
Intersurgical’s BVM was marketed as being medically safe and to be used where there’s no time to check patient history, and to reuse equipment that can become contaminated because the bag prevents cross infection from blood, vomit and secretions.
The BVM consists of a flexible air bag which is attached to a face mask via a shutter valve. When the face mask is applied properly and the bag is squeezed, it forces air through the patient’s lungs. When it’s released, it self inflates which draws air/oxygen that’s regulated by the cylinder. If the valve becomes stuck during this process, there may not be air/oxygen coming in or out. This could put a patient’s life in danger as the whole function of the BVM is to resuscitate an individual.
Affected devices
The affected devices are reportedly as follows:
| REF number | LOT number | NHS Supply Chain Code |
|---|---|---|
| 7150000, 7151000, 7151001, 7152000, 7152007, 7152060, 7153000, 7154000, 7155000, 7156000 | All lot numbers up to and including lot 370253 | 7150000 is FDE656 7152000 is FDE658 7153000 is FDD4288 |
| 7152003 | All lot numbers up to and including lot 1170673 | N/A |
| 7150006, 7151006, 7152004, 7152005, 7152006, 7152009, 7152012, 7152014, 7152061, 7153006, 7153008 | All lot numbers up to and including lot 31753734 | N/A |
| 7150170, 7151170, 7152170, 7152172, 7153170 | All lot numbers up to and including lot 170504 | N/A |
The field safety notice dictates that Intersurgical must inform all users of the product about the lot numbers listed above, and users must also check the function of the product before use.
The content of this post/page was considered accurate at the time of the original posting and/or at the time of any posted revision. The content of this page may, therefore, be out of date. The information contained within this page does not constitute legal advice. Any reliance you place on the information contained within this page is done so at your own risk.
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