Concepedia

Device Malfunction Reporting

Device Malfunction Reporting is a formal regulatory and academic concept referring to the systematic documentation and submission of instances in which a medical device fails to perform as intended, potentially leading to patient harm or compromised clinical outcomes, within the broader domain of post-market surveillance mechanisms.

63

Publications

2.3K

Citations

320

Authors

139

Institutions

Publications per year

2017–2026

22

Parents

Publications

63

Adverse occurrences in intensive care units

N. S. Abramson · JAMA · 1980 · 134 citations

, , +16

Analysis of Safety-Critical Computer Failures in Medical Devices

Homa Alemzadeh, Ravishankar K. Iyer, Zbigniew Kalbarczyk et al. · IEEE Security & Privacy · 2013 · 128 citations · Full text

, , +16

Implantable Cardioverter-Defibrillator Therapy Before Death

Annika Kinch Westerdahl, Johanna Sjöblom, Anne‐Cathrine Mattiasson et al. · Circulation · 2013 · 126 citations

, , +12

Adverse Occurrences in Intensive Care Units

Norman S. Abramson · JAMA · 1980 · 125 citations

, , +16

Risk of Device Malfunction in Cancer Patients with Implantable Cardiac Device Undergoing Radiotherapy: A Population‐Based Cohort Study

Tomás Zaremba, Annette Ross Jakobsen, Mette Søgaard et al. · Pacing and Clinical Electrophysiology · 2015 · 110 citations

, , +17

1–5 of 63

Authors

320

  1. JM
    Jaffar M. Khan

    National Heart Lung and Blood Institute, United States

    2 publications · 58 citations

    2

    h-index

  2. RW
    Ron Waksman

    MedStar Washington Hospital Center, United States

    2 publications · 58 citations

    2

    h-index

  3. HH
    Hayder Hashim

    MedStar Washington Hospital Center, United States

    2 publications · 58 citations

    2

    h-index

  4. CP
    Carlo Pace Napoleone

    University of Bologna, Italy

    2 publications · 67 citations

    2

    h-index

  5. RO
    Richard O. Cummins

    University of Washington, United States

    2 publications · 65 citations

    2

    h-index

1–5 of 320

Institutions

139

  1. Center for Devices and Radiological Health

    Rockville, United States

    5 h-index

    6 publications

    103 citations

  2. University College London

    London, United Kingdom

    4 h-index

    5 publications

    153 citations

  3. National Heart Lung and Blood Institute

    Bethesda, United States

    3 h-index

    11 publications

    843 citations

  4. National Institutes of Health

    Bethesda, United States

    3 h-index

    4 publications

    89 citations

  5. Erasmus MC

    Rotterdam, The Netherlands

    2 h-index

    3 publications

    88 citations

  6. Heart and Diabetes Center North Rhine-Westphalia

    Bad Oeynhausen, Germany

    2 h-index

    2 publications

    67 citations

  7. University of Pennsylvania

    Philadelphia, United States

    2 h-index

    5 publications

    98 citations

  8. MedStar Washington Hospital Center

    Washington D.C., United States

    2 h-index

    27 publications

    747 citations

1–8 of 139

Venues

  1. JAMA

    5 publications · 340 citations

    5

    h-index

  2. PubMed

    Repository · 3 publications · 55 citations

    3

    h-index

  3. Pacing and Clinical Electrophysiology

    PACE · 3 publications · 220 citations

    3

    h-index

  4. European Journal of Cardio-Thoracic Surgery

    EJCTS · 2 publications · 67 citations

    2

    h-index

  5. Circulation

    2 publications · 200 citations

    2

    h-index

1–5