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Table 2 Cases of fetal or neonatal death associated with cardiotocography reported to the U.S. FDA, March 31, 2009 to March 31, 2019; subset where reports indicate probable maternal heart rate artefact

From: Unrecognized maternal heart rate artefact in cases of perinatal mortality reported to the United States Food and Drug Administration from 2009 to 2019: a critical patient safety issue

Event type

Number of cases (% of all 47 cases)

Recommendation to verify fetal life by alternate means prior to cardiotocography

(% of cases of that event type)

Recommendation to use signal ambiguity detection technology

(% of cases of that event type)

Recommendation to improve response to alarms from signal ambiguity detection technology

(% of cases of that event type)

Total cases with recommendation to verify fetal life by alternate means prior to cardiotocography, use signal ambiguity detection technology, or respond to alarms from such technology. (% of case of that event type)

Antepartum fetal death

14 (30%)

9 (60%)

6 (40%)

1 (7%)

9 (60%)

Cannot distinguish antepartum from intrapartum fetal death

17 (36%)

5 (29%)

4 (24%)

0 (0%)

6 (35%)

Cannot distinguish between antepartum fetal death, intrapartum fetal death, or neonatal death

2 (4%)

0 (0%)

0 (0%)

1 (50%)

1 (50%)

Intrapartum fetal death

3 (6%)

0 (0%)

1 (33%)

2 (67%)

2 (67%)

Cannot distinguish intrapartum fetal death from neonatal death

3 (6%)

0 (0%)

1 (33%)

3 (100%)

3 (100%)

Neonatal death

8 (17%)

0 (0%)

2 (25%)

3 (38%)

4 (50%)

Total

47

14 (29%)

14 (29%)

10 (20%)

25 (53%)