PERFUSION SYSTEMS

Manufacturer adverse-event records for PERFUSION SYSTEMS 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 · 2011–2026 · thin-book · elevated Death-code · balanced

Death-code intensity

PERFUSION SYSTEMS carries an elevated Death-code share

Death-coded event_type rows are 94 of 4,996 (1.88% · elevated tercile among 443 manufacturers). Absolute volume is thin-book.

What the Death-code reading shows for PERFUSION SYSTEMS

The standout signal for PERFUSION SYSTEMS is Death-code intensity: 1.88% of 4,996 reports (elevated tercile), while absolute volume is thin-book.

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 20 device types, led in this extract by Malfunction at 4,275 (85.6% of event_type total). Peak single-year volume reaches 1,672 reports across 16 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,996
Total Reports
94
Event-type Death
626
Injury Reports
20
Device Types

Event Types

Malfunction 4,275 (85.6%)
Injury 626 (12.5%)
Death 94 (1.9%)
1 (0.0%)

Patient Outcomes

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

4,184 (81.8%)
Required Intervention 466 (9.1%)
Other 106 (2.1%)
Hospitalization 99 (1.9%)
Death 84 (1.6%)
R 66 (1.3%)
Life Threatening 38 (0.7%)
H 28 (0.5%)
L 19 (0.4%)
D 12 (0.2%)
O 7 (0.1%)
Disability 5 (0.1%)
S 2 (0.0%)

Yearly Trend

11
2011: 5
12
2012: 59
13
2013: 52
14
2014: 77
15
2015: 40
16
2016: 32
17
2017: 43
18
2018: 46
19
2019: 82
20
2020: 93
21
2021: 129
22
2022: 464
23
2023: 1,096
24
2024: 817
25
2025: 1,672
26
2026: 289