Two thousand ventilators are in use in British hospitals are in risk of suddenly closes down due to an electrical fault that resulted in global safety anxiety.
Hospitals have been ordered to replace ventilators after Philips Respironics said their breathing support devices may suddenly stop working, in some cases without activation warning anxiety.
The Medicines and Health Products Regulatory Agency (MHRA) reported that problem pertaining to the number of electrical faults in devices that can result in unexpected shutdown leading to loss of ventilation”.
It says there have been five cases of blackouts in UK not yet of which included patient harm. There were 389 reports worldwide. of failures, including one where patient died and four were seriously injured. AT six of in total cases, warning anxiety is not sound.
Philips Respironics is one of several manufacturers who increased production of ventilators during a pandemic. MHRA brought in a fast approval process for ventilators and other medical devices in response to Covid-19.
Affected machines include invasive and non-invasive ventilators used for support Patients in critical nursing and intensive care units.
MHRA said root cause of in problem not yet known and remained under investigation, but that Philips Respironics currently there was no “permanent solution” to fix it.
Dutch medical equipment the company said it does not advise customers to remove vulnerable devices because of “extremely low incidence” of problems and instead recommends steps to reduce risks such as connecting fans to remote anxiety system in in case the main alarm fails.
But the MHRA ordered hospitals and healthcare providers to find alternative ventilators and train staff. use them, and said affected devices should be removed from use by the end of May. In the meantime, doctors should step up surveillance of patients and ensure backup fan always available.
The regulator said hospitals would still be able to use affected fans, if any “risk of serious patient harm due to lack of accessibility”, but that “thorough risk the evaluation should be completed and additional monitoring should be used.”
“If medical workers do not notice, ventilation failure can have serious health consequences on patients,” the statement said. “This may include hypoxia, which can result in long-term cognitive impairment in patient. There is also a risk of death if patient without ventilation for a long period of time.”
safety the warning comes after the line of Other problems with Philips Respironics fans. In January issue what could lead suddenly device outage was reported in United States. Philips stated that this was due to “manufacturing issue” for expired adhesive and affects only a certain batch.
The shutdowns were also informed in September 2020 when MHRA recalled about 300 Philips ventilators. in UK was on risk of suddenly stopped working. The company stated that issue related “specifically to V60 fans with some circuit board board assembly” and can be fixed with maintenance schedule.
A separate warning was issued in June 2021 due to degradation of foam is used in some ventilators and sleep apnea machines which might lead users who inhale carcinogenic chemicals. latest safety The warning applies to Philips V60, V60 Plus and V680 ventilators and affects approximately 105,000 devices worldwide and 2000 in UK, Philips said. The Department of Health has made arrange for the supply of replacement ventilators to hospitals that need them.
Dr. Ben Messer, consultant in intensive care at Newcastle Hospitals NHS Foundation Trust and spokesman for The British Thoracic Society said the recall was “significant” as the devices were “very widely used”. in critical nursing departments” for people with lung disease and Covid-19, especially who need a lot of oxygen or have been weaned off more intensive support.
“It’s frustrating because they are outstanding machines,” he said. He added is trust in Philips will be dented unless cause of in problem could be identified and corrected. “If they say, ‘No, we’re not going to fix This problem’, This hard imagine what philips will paint in very positive light”.
Helen Hughes, Executive Director of charity Patient Safety Learning, said there was “significant patient safety concern” that some Philips devices may remain in use until replacements are found.
This is reported by Philips Respironics. safety was his number one priority” and apologized to “any patient or medical professional who could have any concerns result of in safety notification. He has set up a team to deal with with fan shutdown messages.
The spokesman said: “The V60 ventilator was in service for almost 10 years with high reliability record. Every complaint one there are too many complaints, and if there are issue reports, then we will take each individual complaint seriously, deal with it transparently, and report it to the appropriate competent authorities.”
