This article has been updated with a comment from Dräger.

The FDA has issued a warning letter to Dräger Medical following an inspection of its Andover, Mass., facility in August and September 2019.

The agency faulted the patient-monitoring company for failing to file for 510(k) clearance of its Infinity acute care system (IACS) M540 although it made “significant modifications” to the device that could affect its safety and effectiveness.

The warning letter also cited Dräger for failure to:

• Include risk analysis in device validation.
• Confirm that device design output meets input requirements.
• Define and document design output to allow evaluation of conformance to design input requirements.
• Establish and maintain procedures for implementing corrective and preventive actions.

Dräger said it received the warning letter, which was dated January 17, 2020. It has 15 days from the day it received the letter to file a response with the FDA.

“The letter was specific to the process taken with respect to one specific patient monitoring line,” Dräger Medical Systems president Carsten Kossler said in an email to Medical Design & Outsourcing. “We take this matter very seriously and continue to actively work with the FDA to address the process issues raised.”