Durability testing of a completely implantable electric total artificial heart

Conrad M. Zapanta, Alan J. Snyder, William J. Weiss, Thomas J. Cleary, John D. Reibson, Marjorie A. Rawhouser, Jeffrey P. Lewis, William S. Pierce, Gerson Rosenberg

Research output: Contribution to journalArticlepeer-review

13 Scopus citations

Abstract

In vitro durability testing was conducted on the Penn State/3M electric total artificial heart (ETAH) to determine device durability and to evaluate device failures. A specialized mock circulatory loop was developed for this testing. Customized software continuously acquired data during the test period, and failures were analyzed using FMEA (failure modes and effects analysis) and FMECA (failure modes, effects, and criticality analysis) principles. Redesigns were implemented when appropriate. Reliability growth principles were then applied to calculate the 1 and 2 year reliability. The 1 and 2 year reliability of the Penn State/3M ETAH was shown to be 96.1% and 59.9%, respectively, at 80% confidence.

Original languageEnglish (US)
Pages (from-to)214-223
Number of pages10
JournalASAIO Journal
Volume51
Issue number3
DOIs
StatePublished - May 2005

All Science Journal Classification (ASJC) codes

  • Biophysics
  • Bioengineering
  • Biomaterials
  • Biomedical Engineering

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