An error with a resuscitation system has been reported to risk damage to lungs, according to information released by the Medicines and Healthcare Products Regulatory Agency (MHRA).
Manufactured by Intersurgical, the manual resuscitation system – named as the “Bag valve mask” (BVM) – risks damage to lungs due to the potential for excess pressure being delivered by the system.
Given that the defect is with a resuscitation system, this recall is an important one as lives may be at risk as a result of it.
According to reports from the MHRA, valves in the resuscitation system may be incorrectly orientated, which can result in overpressure of the bag. Healthcare professionals, organisations and applicable institutions are being asked to quarantine affected devices and use alternatives and acquire replacements.
The other option where an alternative is not available is for checks to be done to ensure orientations are correct on affected devices. Of course, with the issue here being defective life-saving resuscitation devices, something is needed in the event a replacement is not readily available.
This is not the first case of a life-saving medical device with a small defect that can end up causing big issues.
More often than not, it can be such small defects or problems with devices that leads to them becoming dangerous or defective. When it comes to medical devices, the duty of care to ensure that the problem is resolved is incredibly important.
First published by Author on April 18, 2018
Posted in the following categories: Medical Recalls and tagged with medical devices | mhra | recalls