9/30/97 EZ-Flow 480 Ambulatory Infusion Pump 1058 devices. Defective software may cause over infusion when using the PCA mode. 1/9/98 confirmed a patient death due to a software logic error related to use in the patient controlled analgesia (PCA) mode caused the lethal dose of morphine sulfate. Two non-fatal incidents in 1996 also occurred.Read More
Schedule Discussion with John F. Murray, Jr.
John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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