Spelling errors, Chinese labelling, and a total lack of legal declarations of conformity were among the issues noted with ventilators procured from China following an investigation ordered by the HSE.
Other issues noted in the probe undertaken by the Health Products Regulatory Authority (HPRA) included mismatched certificates of quality standard and unsubstantiated statements of device compatibility regarding machines supplied by festival management company Roqu Media International.
The report was commissioned by the HSE and delivered in June 2020.
Seen by the, the report into the underlying documentation accompanying ventilators procured at the beginning of the Covid-19 pandemic found “potentially significant non-compliances”.
It said the machines in question “should not be put into service at this time”.
Meanwhile, questions remain as to where the ventilators’ compatibility issues were first noted, with the report commenting that some were caught at “commissioning”, while five of the machines failed “on site”.
Neither the HSE nor the HPRA would comment as to whether or not “on site” meant the machines in question had failed within a medical facility, such as a hospital, although the HPRA report stresses the devices were never deployed in clinical practice.
Inconsistencies also exist between numbers detailed in official HSE reports and those detailed in the HPRA report.
Five separate device types were reviewed by the HPRA, at least four of which, representing 65 machines, emanated from a deal struck with festival management company Roqu Media International to bring 328 ventilators into Ireland.
Of those 65 machines, 27 failed before deployment, four of them “on site”.
Some 31 of those ventilators were Eternity SH300s, produced by a company in Beijing, which holds a valid CE certificate. However, none of the machines were supplied with that certificate, meaning the HPRA could not verify their authenticity. Two brochures supplied with the devices referenced different certification bodies.
Two of the machines were Aeonmed VG70s, which arrived to Ireland with a CE certificate initially obtained by the Chinese outpost of Ireland's IDA.
However the HPRA stressed in the report that it wasn’t clear if that certificate in fact related to the machines provided by Roqu Media International, one of which had failed at commissioning.
While product brochures for both machines appeared to be compliant, the labelling on the devices showed no CE mark, while all the text was in Chinese.
Again, the HPRA said the two machines should not be placed on the Irish or European markets until the “significant non-compliances” noted had been investigated.
In terms of the 20 PA700 machines delivered by Roqu – all 20 of which failed quality testing at commissioning – a CE certificate was supplied which was just under five years out of date, the authenticity of which the HPRA did not verify.
The labelling on these devices was particularly egregious, the HPRA said, with no CE mark and a number of issues involving the relevant website address.
The product brochure for these machines noted the distributor was a Perlong Medical, whose website appeared near-identical to that of Perlove Medical, a company based in the city of Nanjing that the HPRA had prior knowledge of, which had valid EU certification – but not for ventilators.
The 12 Boaray 5000 devices provided by Roqu were the only ones accompanied with a seemingly valid CE certificate, although a second certificate supplied by the HSE appeared to be two years out of date, which “raises concerns in relation to the authenticity of the products”, the HPRA said.
These machines were also the only ones which matched the original spec in the HSE’s contract with Roqu, and the only ones not to fail at commissioning, although none of them were accompanied with a user manual.
Roqu Media International did not respond to request for comment by the.