FDA Slams Massachusetts Firm for Unapproved Device Changes

The FDA hit Draeger Medical Systems with a warning letter for failing to submit a new 510(k) premarket notification for “significant changes” it made to its patient monitoring device.

The company’s Andover, Massachusetts facility made substantial modifications to its Infinity Acute Care System M540, a continuous patient monitoring system for use in the hospital at the bedside or during transport, but didn’t file the required 510(k) submissions, the agency said.

The changes the company made to its multi-parameter monitoring system could impact its safety and effectiveness and lead to patient injury or death, the agency warned, as the system might fail to detect or alert users to life-threatening arrythmias in patients.