Table 3. Terms in the MAUDE Database Associated With the Highest Percentages of Missed Deaths.
| Term | Total No. | No. | % of Missed death reports (with 95% CI when calculated)a | ||
|---|---|---|---|---|---|
| Reports | Nondeath reports | Reports reviewed | Deaths that were not classified as deaths | ||
| Patients died | 1462 | 1019 | 100 | 100 | 70 (69-70) |
| Unreported cause of death | 5 | 3 | 3 | 3 | 60 |
| Babies died | 6 | 3 | 3 | 3 | 50 |
| Patient who died | 148 | 64 | 64 | 64 | 43 |
| Baby died | 54 | 20 | 20 | 20 | 37 |
| Patient later expired | 431 | 153 | 100 | 100 | 35 (35-35) |
| Patients who expired | 27 | 9 | 9 | 9 | 33 |
| Patients died | 74 | 25 | 25 | 24 | 33 |
| Fatal outcome | 140 | 49 | 49 | 40 | 31 |
| Patients expired | 125 | 38 | 38 | 37 | 30 |
Abbreviation: MAUDE, manufacturer and user facility device experience.
a
Percentage of missed deaths was equal to the number of deaths identified on manual review /(number of deaths identified on manual review + number of known deaths) × 100. A 95% confidence interval was calculated for this percentage in the cases in which only a subset of reports were reviewed.