Two thousand ventilators being used in UK hospitals are at risk of suddenly shutting down due to electrical faults that have led to a global safety alert.
Hospitals have been ordered to source replacement ventilators after Philips Respironics said its breathing support devices could suddenly stop working, in some cases without activating a warning alarm.
The Medicines and Healthcare products Regulatory Agency (MHRA) said the problem related to “a number of electrical faults in the devices, which can result in an unexpected shutdown, leading to loss of ventilation”.
It said there had been five reported cases of shutdowns in the UK so far, none of which involved patient harm. Globally, there have been 389 reports of failures, including one where the patient died and four where they were seriously injured. In six of the total cases, the warning alarm didn’t sound.
Philips Respironics is one of several manufacturers that increased production of ventilators during the pandemic. The MHRA brought in a fast approval process for ventilators and other medical devices in response to Covid-19.
The MHRA said the root cause of the problem was not yet known and remained under investigation, but that Philips Respironics currently had “no permanent solution” to correct it.
Helen Hughes, chief executive of Patient Safety Learning, said there was a “significant patient safety concern” that some Philips devices could remain in use until replacements were sourced.
Source: The Guardian, 9 April 2022
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