Computer Software Experts Opine on Programming Error in Defective Ventilator System

Case Overview

This case involves a now-recalled bedside device used to accommodate medical patients with respiratory disorders such as COPD. In this instance a ventilator of this type was being used to supply oxygen to a sleeping patient in an Alaskan hospital who depended on the device for respiration. One week after the device was purchased, it suddenly ceased functioning, but provided no alarm to indicate that anything had gone wrong. As a result, the patient suffocated before assistance could be rendered. It was alleged that the device’s software contained a fatal flaw that allowed the device to cease functioning without providing any kind of alarm.

Questions to the Medical Device expert and their responses

Are you capable of reading the data stored on the memory card in question to determine whether or not a malfunction was recorded?

Given the relevant files and data, it is possible for me to determine whether an adverse event is recorded, and maybe even determine the cause of the incident that lead to the decedent's death.

About the expert

This experienced software engineer is an expert in the field of medical device product design and development. Earning his Master's degree in Computer Science from Johns Hopkins University, he has contributed to the healthcare industry with the development of numerous devices and associated software. He created the first accessory to allow smart phones to function as portable wheeze monitors, invented a wearable electrocardiograph that runs on Android, and served as the technical product manager for a line of ventilators. He currently owns and operates a consulting firm focusing on medical technologies.

E-037773

Specialties:

Medical Device