PHILIPS MEDICAL SYSTEMS

Manufacturer adverse-event records for PHILIPS MEDICAL 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 · 1993–2026 · heavy-book · elevated Death-code · injury-light

Volume signature

PHILIPS MEDICAL SYSTEMS sits in the heavy MAUDE book

PHILIPS MEDICAL SYSTEMS accounts for 108,834 FDA MAUDE reports (#30 of 443, heavy-book tercile). Death-coded event_type share is 2.24% (elevated); Injury share 1.5% (injury-light).

What the volume reading shows for PHILIPS MEDICAL SYSTEMS

The standout signal for PHILIPS MEDICAL SYSTEMS is filing volume: 108,834 adverse-event reports in FDA MAUDE (#30 of 443, heavy-book). Death-coded event_type share sits at 2.24% (elevated).

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair PHILIPS MEDICAL SYSTEMS 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 104,226 (95.8% of event_type total). Peak single-year volume reaches 13,012 reports across 34 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

108,834
Total Reports
2,440
Event-type Death
1,685
Injury Reports
20
Device Types

Event Types

Malfunction 104,226 (95.8%)
Death 2,440 (2.2%)
Injury 1,685 (1.5%)
Other 365 (0.3%)
118 (0.1%)

Patient Outcomes

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

104,814 (96.2%)
Death 2,295 (2.1%)
Other 699 (0.6%)
Required Intervention 486 (0.4%)
Life Threatening 389 (0.4%)
R 71 (0.1%)
Hospitalization 40 (0.0%)
L 37 (0.0%)
O 36 (0.0%)
Disability 10 (0.0%)
S 7 (0.0%)
D 6 (0.0%)
Congenital Anomaly 5 (0.0%)
Invalid Data 2 (0.0%)
H 1 (0.0%)

Yearly Trend

93
1993: 1
94
1994: 9
95
1995: 1
96
1996: 8
97
1997: 18
98
1998: 15
99
1999: 13
00
2000: 7
01
2001: 23
02
2002: 98
03
2003: 192
04
2004: 298
05
2005: 373
06
2006: 421
07
2007: 613
08
2008: 850
09
2009: 1,757
10
2010: 2,401
11
2011: 1,506
12
2012: 4,742
13
2013: 9,008
14
2014: 10,840
15
2015: 10,532
16
2016: 11,698
17
2017: 11,999
18
2018: 13,012
19
2019: 12,803
20
2020: 10,707
21
2021: 1,679
22
2022: 87
23
2023: 928
24
2024: 893
25
2025: 1,142
26
2026: 160