The FDA released an inspection report into Cleveland-based Philips Medical Systems, part of Amsterdam-based Royal Philips, stating the company mishandled thousands of complaints.
The FDA's report lays out nine observations agency representatives made during an inspection of the facility that took place during the summer of 2017. The agency specified its observations are "inspectional observations, and do not represent a final agency determination regarding [the company's] compliance," according to the report.
Among its key observations, the FDA alleged Philips had not adequately investigated complaints involving the possible failure of devices to meet specifications.
Out of 133,845 complaints Philips received from July 2016 to July 2017, 97 percent were closed based on assigned hazard-harm matrix symptom codes. However, since January 2016, the FDA noted 3,623 complaints that received low hazard-harm matrix severity levels had a high severity level on the risk matrix, suggesting the potential for serious injury or death.
At least 1,792 of these 3,623 complaints should have been transferred to Philips' complaint handling unit for further investigation based on the company's own work instructions, according to the report.
The FDA also alleged Philips' risk analyses were inadequate. The agency said Philips used a hazard-harm matrix to determine if a complaint from a service order must be forwarded to the complaint handling unit for potential investigation, but said it's "unclear why some of the symptom codes which are assigned a [certain] severity level … are forwarded to the CHU and why some are not."
In an emailed statement to Becker's Hospital Review March 19, a Philips spokesperson said the company had prepared and submitted a formal response to the FDA's inspection, and is in discussions with the agency to address its observations.
"Our products are complex and we use our complaints process to capture all customer and field service engineer feedback related to the performance and improvement of products," the company statement reads. "As part of our overall drive for continuous improvement and patient safety, Philips takes a conservative approach and evaluates every service order we receive to determine if an additional investigation is required based on the event."
To access the FDA's report, click here.