PlainHospital

ST PAUL

Manufacturer adverse-event records for ST PAUL 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 · 1997–2024 · heavy-book · quiet Death-code · injury-light

Injury-mix signature

ST PAUL is lighter on Injury codes

Injury-coded event_type share is 0.9% (injury-light tercile) beside 0.06% Death-coded (quiet). Volume band: heavy.

What the Injury-mix reading shows for ST PAUL

The standout signal for ST PAUL is Injury-mix: 0.9% Injury-coded (injury-light) beside 0.06% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair ST PAUL with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 20 device types, led in this extract by Malfunction at 34,499 (99.0% of event_type total). Peak single-year volume reaches 17,415 reports across 9 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

34,841
Total Reports
21
Event-type Death
321
Injury Reports
20
Device Types

Event Types

Malfunction 34,499 (99.0%)
Injury 321 (0.9%)
Death 21 (0.1%)

Patient Outcomes

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

34,477 (99.0%)
Required Intervention 161 (0.5%)
Hospitalization 73 (0.2%)
Other 47 (0.1%)
Life Threatening 20 (0.1%)
Death 15 (0.0%)
R 14 (0.0%)
O 5 (0.0%)
D 3 (0.0%)
H 2 (0.0%)

Devices (20)

Device Reports
Pump, Infusion 23,333
Set, Administration, Intravascular 7,777
Pump, Infusion, Pca 1,168
Warmer, Thermal, Infusion Fluid 865
Warmer, Blood, Non-Electromagnetic Radiation 350
Ventilator, Emergency, Powered (Resuscitator) 249
Device, Warming. Blood And Plasma 245
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 188
Oximeter 119
Port & Catheter, Implanted, Subcutaneous, Intravascular 108
Tube Tracheostomy And Tube Cuff 63
Accessories, Pump, Infusion 59
Tube, Tracheal (W/Wo Connector) 48
Ventilator, Continuous, Facility Use 43
System, Thermal Regulating 35
Tube, Tracheostomy (W/Wo Connector) 30
Anesthesia Conduction Kit 29
Circuit, Breathing (W Connector, Adaptor, Y Piece) 11
Pump, Infusion, Enteral 11
Needle, Hypodermic, Single Lumen 10

Yearly Trend

97
1997: 1
17
2017: 1
18
2018: 155
19
2019: 77
20
2020: 4,048
21
2021: 7,139
22
2022: 17,415
23
2023: 5,910
24
2024: 95

Read our methodology - how this data is sourced, computed, and verified.