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EMC MDQS Page 12

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of apnea monitors, CDRH determined the devices were so susceptible to expected EMD to be sufficiently hazardous and in violation of the Act. The manufacturer agreed to recall and correct the products.

3. Safety Alert: Ventilators

Although the device complied with IEC 60601-1-2, the manufacturer determined in the laboratory that the units displayed functional irregularities, such as a flashing display, when exposed to high ESD or EMD fields, at levels above the IEC standard. Because normal operation would resume in a few seconds and there was little likelihood of patient injury, the firm issued a safety alert to purchasers recommending a proper EM environment. The firm concurrently developed improved software that provides further immunity to EMD. The software replacement was performed voluntarily by the manufacturer and at no cost to the customers. The enhanced software constituted an upgrade.

Inspection Reports and Observations

Investigators may discuss any EMC issue with a firm. All concerns should be documented in the Establishment Inspection Report (EIR). The EIR should include information on the DMR, product testing, qualifying laboratories, complaint handling, failure investigations and design controls, as appropriate. Investigators must document design aspects of inspectional information using the Design Control Inspectional Strategy (DCIS) report from June 1, 1997 through May 31, 1998. The design control questions in Appendix E are to be used only for reference in understanding the scope of the DCIS questions as they apply to EMC issues.

EMI issues should NOT be cited on the Form FDA 483, Inspectional Observations, unless they can be related to GMP deficiencies.

Examples of non-design GMP deficiencies that may be cited on the FDA 483 are:

  1. failure to conduct an investigation of an MDR - reportable EMI malfunction or injury;
  2. failure to file an MDR for a reportable EMI event;
  3. failure to maintain appropriate environmental controls for processing of electronic components known to be susceptible to ESD; or
  4. failure to maintain proper incoming controls for electronic components.

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