PlainHospital

PHILIPS NORTH AMERICA LLC

Manufacturer adverse-event records for PHILIPS NORTH AMERICA LLC 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 · 2019–2026 · heavy-book · elevated Death-code · injury-light

Injury-mix signature

PHILIPS NORTH AMERICA LLC is lighter on Injury codes

Injury-coded event_type share is 2.5% (injury-light tercile) beside 1.30% Death-coded (elevated). Volume band: heavy.

What the Injury-mix reading shows for PHILIPS NORTH AMERICA LLC

The standout signal for PHILIPS NORTH AMERICA LLC is Injury-mix: 2.5% Injury-coded (injury-light) beside 1.30% Death-coded, on a heavy-book footprint.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair PHILIPS NORTH AMERICA LLC 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 19,842 (96.2% of event_type total). Peak single-year volume reaches 6,697 reports across 8 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

20,624
Total Reports
268
Event-type Death
511
Injury Reports
20
Device Types

Event Types

Malfunction 19,842 (96.2%)
Injury 511 (2.5%)
Death 268 (1.3%)
Other 2 (0.0%)
No answer provided 1 (0.0%)

Patient Outcomes

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

19,739 (95.5%)
Life Threatening 275 (1.3%)
Death 263 (1.3%)
Other 194 (0.9%)
Required Intervention 98 (0.5%)
Hospitalization 39 (0.2%)
R 24 (0.1%)
L 17 (0.1%)
D 13 (0.1%)
O 4 (0.0%)
H 3 (0.0%)
S 1 (0.0%)

Devices (20)

Device Reports
Automated External Defibrillators (Non-Wearable) 17,112
Detector And Alarm, Arrhythmia 1,266
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) 861
Over-The-Counter Automated External Defibrillator 603
Ventilator, Non-Continuous (Respirator) 524
Electrode, Circular (Spiral), Scalp And Applicator 47
System, Imaging, Pulsed Doppler, Ultrasonic 35
Alarm, Blood-Pressure 34
System, Measurement, Blood-Pressure, Non-Invasive 34
Electrocardiograph 19
Ventilator, Continuous, Facility Use 9
System, Network And Communication, Physiological Monitors 8
Ventilator, Continuous, Non-Life-Supporting 7
Computer, Diagnostic, Programmable 6
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 6
Dna Probe, Trichomonas Vaginalis 5
Oximeter 5
System, Nuclear Magnetic Resonance Imaging 4
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use 4
Cable, Electrode 3

Yearly Trend

19
2019: 1
20
2020: 16
21
2021: 6,697
22
2022: 5,464
23
2023: 3,843
24
2024: 2,539
25
2025: 1,864
26
2026: 200

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