ROBSTOWN, Texas — A Robstown woman is searching for answers following the death of her mother; which she blames on faulty medical devices.
Stephanie Saenz’s mother, Julie Vedia, had been on a CPAP machine since 2018. In January 2021, she was switched to a new machine, the Trilogy 100 from Philips Respironics. From that time, up until her death in September, Vedia was admitted to the hospital more than 40 times.
“That’s with ER visits, intubation, therapy, and we couldn’t figure out the reason why she had to go to the hospital that many times,” Saenz said. “She would go to the hospital, get intubated, do rehab, come home, and then a week later, she was back in the hospital, and we couldn’t figure out why.”
A week after her mother’s passing, Saenz received a letter from Philips Respironics, saying the company recalled more than a dozen medical devices. According to the recall, the foam used in certain devices could break down, causing the foam to be inhaled or swallowed, which could cause serious and potentially life-threatening injuries.
“We had looked up the symptoms, and it was stuff that would irritate the airways, the lungs, and it just made sense,” Saenz said.
Before receiving the letter, the family assumed Vedia’s pre-existing illness was the cause of her death and they accepted it; but the recall letter changed that.
“We had a good week to just be like, ‘maybe mom was just tired, maybe her body was just tired and gave out,’” she said. “And then we get that letter, and it just sets you back. We were already accepting that mom was not here, and it was because she was tired. But, what if she wasn’t tired, what if it was these machines that were doing this to her lungs?”
In June, Vedia was switched from the Trilogy to the DreamStation, another recalled machine. Saenz said towards the end of her mother’s life, she was sedated more and more, causing her to use the machine more often, and now she wonders if that was adding to the decline of her mother’s health.
“We knew one day that her pre-existing conditions would take her life, but not like this,” Saenz said. “It hurts because my children were left without a grandma, her life was cut short. My dad was with my mom for 30 years, and now he has to come home every single day from work to nobody.”
To make matters worse, Saenz and her family cannot get involved in a current class-action lawsuit against the company, because they do not have the serial numbers for any of the machines she was on before she died.
“The lawyers for the class-action can look back and say 'these machines were on recall, we need to help them', but I didn’t have the information,” she said.
While it is too late for anything to happen to save her mother, Saenz hopes Philips Respironics will make things right, so other families do not have to experience the same heartbreak as her family.
“They need to make this right, not only for people like my mother, but for people who depend on these machines to sleep at night, or who depend on these machines to live comfortably,” she said.
KRIS 6 News reached out to Philips Respironics, the company responded with the following statement:
"Regarding estimated timing, we are working to address this issue as expeditiously as possible. Given the number of devices currently in use (estimated at 3 to 4 million units globally based on production and shipment data – about half are in the U.S.), we expect to complete the repair and replacement programs in each country within approximately 12 months from obtaining the relevant regulatory clearances..."
"...To address affected devices, Philips has mobilized the necessary resources across the company to correct the foam component quality issue that we have identified. Our priority is to replace the foam in all the affected devices either by repair or replacement with like devices with the new foam. The repair and replacement program will be at no cost to consumers in the U.S."