The FDA has warned Cardiac Designs for poor design validation and complaint-handling procedures.
A June 16 to July 2 inspection of the company’s Round Rock, Texas, plant found no records demonstrating that the ECG Check Application software was validated. The plant produces the software and the ECG Check Wireless Lead Cardiac Monitor.
The agency also dinged the firm’s customer requirements and complaints procedure. Cardiac Design uses a contractor to receive and initially document all communications, but the procedure doesn’t address this practice, the Aug. 7 warning letter says.
Further, the company received a complaint over the possible failure of the ECG Check monitor and software to detect an abnormal heart condition, but there was no record the complaint was evaluated to determine if it was reportable to the FDA.
Cardiac Designs could not be reached for comment by press time. View the warning letter at www.fdanews.com/09-08-15-CardiacDesigns.pdf. — Michael Cipriano