According to MassDevice, The U.S Food and Drug Administration (FDA) recently publicized a warning letter it sent to Cardiac Designs discussing issues associated with the company’s failure to provide proper design validation. The letter also addressed complaints over a electrocardiogram monitor designed by the company.
Cardiac Designs Company
Cardiac Designs, a privately held company headquartered in Park City Utah, is a leading provider of personal cardiac monitoring products. In March 2013, the company won FDA 510(k) clearance for an electrocardiogram monitor to be used with the iPhone.
The letter followed an inspection of the company’s Round Rock, Texas facility in June. According to an FDA investigator, Cardiac Designs and its contract company had not established validation procedures
Additional Observations Covered in the Warning Letter
In additional to their failure to establish validation procedures, the company was also scrutinized for failure to handle its complaints. Of the 1,147 complaints received by the contracted company, none had been reviewed by Cardiac Designs.
The company had also failed to properly document at least 87 complaints between April 4 and June 15.
This included a complaint sent on December 16th which stated stated the ECG monitor failed to detect an abnormal heart condition. The complaint was never evaluated.