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EDENTEC REPLACES DEFECTIVE CAPACITORS IN ADULT/INFANT APNEA MONITORS

This article was originally published in The Gray Sheet

Executive Summary

EDENTEC REPLACES DEFECTIVE CAPACITORS IN ADULT/INFANT APNEA MONITORS as part of a recent Class I recall. The recall involved 378 Model 2000W and Model 2000W Option H heart/respiration monitors and five System 700 monitors, which incorporate a recording device. EdenTec says it has contacted all consignees and has replaced capacitors in an unspecified number of "recoverable" devices; the remaining devices are "unrecoverable," according to the firm. The products were distributed domestically and in Germany. The monitors were recalled because they potentially "fail to alarm (both visually and audibly) during an apnea event," according to the FDA's March 31 Enforcement Report (see box below). EdenTec, which was alerted to the problem by a user, says that there have been no reports of serious injury or death associated with the devices. On Jan. 20 and Feb. 8, EdenTec sent letters to customers informing them of the potential problem and asking them to return the device for replacement of the defective capacitor. The firm suspects that one lot of components from its supplier were defective. The same monitor models were recalled for a different reason in mid-1992. In that recall, which was also deemed a Class I action by FDA, the firm repaired malfunctioning printed circuit boards ("The Gray Sheet" July 13, 1992, p. 18). EdenTec says the two recalls are unrelated.

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