Inc. Cardiac Designs

Mylan.
Product: ECG Check Application and ECG Check Wireless Lead Cardiac Monitor
Date: 8/7/2015

1. Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g).

1. Your firm?s ?Design Validations? procedure Revision 1 dated May 22, 2015, states software should be tested according to a test plan and requires the results of this software validation to be maintained in the design history file (DHF). Your firm does not have any records demonstrating the ECG Check Application software was validated.

2. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198.

a. Your ?Customer Requirements and Complaints? procedure revision 2 dated August 24, 2014, is inadequate. Your firm is currently using a contractor to receive and initially document all communications; however, your complaint handling procedure does not address this practice. Further, your procedure does not address how you will receive, review, and verify complaints are being forwarded from your contract complaint handling company, to conduct the complaint investigations.

b. Your ?Customer Requirements and Complaints? procedure revisions 1 and 2, dated May 22, 2013 and August 24, 2014, respectively; require all complaints be documented on your ?Customer Complaint Report Form?. However, your complaint log showed your firm received at least 87 complaints between April 4, 2014 and June 15, 2015 and these complaints were not documented on your ?Customer Complaint Report Form?. Further, there are no records showing these complaints were reviewed to determine if an investigation was necessary or if they were evaluated to determine if they were reportable events as defined in 21 CFR 803.

c. On December 16, 2014, your firm received a complaint indicating a possible failure of your ECG Check Monitor and software to detect an abnormal heart condition. There is no record this complaint was evaluated to determine if it was reportable under 21 CFR 803. In addition, there is no record for this complaint demonstrating the nature and details of the complaint, whether the device failed to meet specifications, or the relationship of the device to the event.

FDA District Office: Dallas district

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