DATASCOPE CORP. - FAIRFIELD

Manufacturer adverse-event records for DATASCOPE CORP. - FAIRFIELD come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 2018–2024 · thin-book · elevated Death-code · injury-light

Volume signature

DATASCOPE CORP. - FAIRFIELD is a thinner MAUDE footprint

DATASCOPE CORP. - FAIRFIELD accounts for 4,032 FDA MAUDE reports (#416 of 434, thin-book tercile). Death-coded event_type share is 3.13% (elevated); Injury share 3.1% (injury-light).

What the volume reading shows for DATASCOPE CORP. - FAIRFIELD

The standout signal for DATASCOPE CORP. - FAIRFIELD is filing volume: 4,032 adverse-event reports in FDA MAUDE (#416 of 434, thin-book). Death-coded event_type share sits at 3.13% (elevated).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 5 device types, led in this extract by Malfunction at 3,783 (93.8% of event_type total). Peak single-year volume reaches 1,007 reports across 7 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,032
Total Reports
126
Event-type Death
123
Injury Reports
5
Device Types

Event Types

Malfunction 3,783 (93.8%)
Death 126 (3.1%)
Injury 123 (3.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

3,756 (93.1%)
Death 133 (3.3%)
Other 83 (2.1%)
Required Intervention 48 (1.2%)
R 5 (0.1%)
D 2 (0.0%)
L 2 (0.0%)
O 2 (0.0%)
Hospitalization 2 (0.0%)
Life Threatening 2 (0.0%)

Yearly Trend

18
2018: 4
19
2019: 796
20
2020: 704
21
2021: 900
22
2022: 1,007
23
2023: 619
24
2024: 2