Two deaths may have occurred in the United States because a medical patch with a heart sensor from Philips did not respond to serious heart problems, writes the Eindhovens Dagblad. More than a hundred other patients suffered injuries due to the malfunctioning medical ‘cabinet’, according to a report from the American medicines authority FDA.
The Dutch medical group warned doctors and hospitals who use a certain type of wearable sensor patch. This concerns the MCOT, which, according to a company spokesperson, is only used in the US.
Such ‘sticky boxes’ can monitor a patient’s heart rhythm for several weeks. That patient does not have to stay in the hospital for monitoring, but can simply go home. However, due to a problem with the software in the device, ECGs that could indicate a dangerous heart rhythm disorder were not forwarded by the computer system to medical specialists, as was actually intended.
Two deaths are linked to the problem, writes the Eindhovens Dagblad. It is said that it also went wrong in another 109 other patients, but without a fatal outcome.
Custom instructions
FDA emphasizes that the devices are not being recalled, but Philips has given doctors updated instructions. A Philips spokesperson told the newspaper that an error in the software configuration was discovered, after which a correction was made. “The service is currently operating normally.” The approximately 130,000 devices in circulation in the US are supplied by Braemar Manufacturing, an American subsidiary of Philips.
After the newspaper report, a spokesperson for the healthcare technology group confirmed to the ANP news agency that the deaths “may have a link” with the device.
Philips had to replace millions of sleep apnea and ventilators worldwide earlier in 2021.
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