Medical devices: underreporting of serious problems with a home apnea monitor : report to the Chairman, Subcommittee on Health and the Environment, Committee on Energy and Commerce, House of Representatives
What people are saying - Write a review
We haven't found any reviews in the usual places.
Other editions - View all
1/88 Checkout only-death 1988 inspection 1988 The manufacturer 70 complaints Aequitron Medical Aequitron's Medical Device alarm Device in-spec alleging Analysis of Aequitron's apnea alarm Device Appendix associated caused or contributed Center for Devices Checkout only-death Device Chronology of Contacts complaint records Contacts Between FDA contributed to serious death of patients December 26 Department of Health Device fully functional device manufacturers Device Reporting Criteria device reporting regulation device reporting requirements Devices and Radiological Evaluation FDA and Aequitron fda's inspection February 12 firm Health and Human health care professional hid file home apnea monitor Human Services identified implementation included injury or death inspection of Aequitron inspection program inspection strategy manufac manufacturing practices medical device reporting Model 8200 monitor notice-of-adverse-findings letter only-death Device in-spec postmarketing surveillance Radiological Health reasonably suggests recommend regulation compliance inspection report to fda reporting policy reporting regulation compliance reporting regulation reports Safety Alert serious injury submitted tion unreported complaints