Monday, 23 May, 2022
HomeNews UpdateGlobal ventilator safety alert from Philips after one patient dies, four injured

Global ventilator safety alert from Philips after one patient dies, four injured

A global safety alert has been issued by Dutch company Philips Respironics that some of its ventilators could suddenly stop working, in some cases without activating a warning alarm.

The Guardian reports that hospitals have been told to source replacement machines, after the UK Medicines and Healthcare products Regulatory Agency (MHRA) said the problem related to “electrical faults… which can result in an unexpected shutdown, leading to loss of ventilation”.

Globally, there have been 389 reports of failures of the devices, including one where the patient died and four where they were seriously injured. In six of the total cases, the warning alarm didnʼt sound.

The alert relates to V60, V60 Plus and V680 Philips ventilators and affects about 105,000 devices globally, and 2,000 in the UK.

Philips Respironics is one of several manufacturers that boosted ventilator production during the pandemic. The affected machines include invasive and non-invasive ventilators used to support patients in critical care and high-dependency units.

A Philips spokesperson said: “The V60 ventilator has been in service for almost 10 years now with a high reliability record. Every complaint is one too many, and if there is a reported issue, we will take each individual complaint seriously.”

Although it currently had “no permanent solution” to correct the fault, the company was not advising customers to remove affected devices, because of the “extremely low incidence” of problems. Instead, it was recommending steps to lower the risks, such as connecting ventilators to a remote alarm system in case the primary alarm fails.

But the MHRA has said affected devices should be removed from use by the end of May.

The safety alert comes after a string of other problems involving Philips Respironics ventilators. In January, in the USA, an issue that could lead to unexpected device shutdown was reported: Philips said it was a “production issue” involving an expired adhesive and affected only a particular batch.

Shutdowns were also reported in September 2020, when a recall was issued by the MHRA, warning that about 300 Philips ventilators in the UK were at risk of suddenly stopping working. The company said that issue related “specifically to V60 ventilators with a certain printed circuit board assembly” and could be corrected through a maintenance schedule.

In June 2021, a separate alert was issued about the degradation of foam used in some ventilators and sleep apnoea machines, which could lead to users inhaling cancer-causing chemicals.

 

The Guardian article – Thousands of ventilators pulled as electrical faults put UK patients’ lives at risk (Open access)

 

USFDA notice – Philips Respironics Recalls Certain V60 and V60 Plus Ventilators for Expired Adhesive that May Cause Ventilator to Stop Working With or Without an Alarm (Open access)

 

See more from MedicalBrief archives:

 

ECMO substantially improved patients — Large study

 

Proning: Some acute ventilator patients have permanent nerve damage

 

Reduction of mechanical ventilation cut ICU deaths — UK Intensive Care Research Centre

 

A low-cost, easy-to-use emergency ventilator in 15 minutes

 

Mkhize: Invasive ventilation of COVID-19 patients should be avoided if possible

 

Too little information of ventilator use in SA to predict patient survival rates

 

National project for 20,000 ventilators delayed another month

 

 

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