PHILIPS MEDICAL SYSTEMS

FDA MAUDE device safety record · 1993–2026

What the Data Shows About PHILIPS MEDICAL SYSTEMS

PHILIPS MEDICAL SYSTEMS is associated with 108,834 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 1993 through 2026. Of the total, 2,440 are coded as death reports and 1,685 as injury reports, with the remainder classified as malfunctions or other event types. These counts reflect reports submitted to the FDA by manufacturers, healthcare facilities, and patients — they are raw signal, not adjudicated safety findings, and higher-volume manufacturers or older product portfolios naturally generate larger raw counts.

The reports span 20 distinct device types attributed to this manufacturer in MAUDE, which means any safety read for PHILIPS MEDICAL SYSTEMS should be reviewed at the device-family level rather than company-wide. Across those devices, 5 distinct event types appear in the record, led by Malfunction at 104,226 reports (95.8% of total). Patient-outcome categorizations are reported across 15 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 34 years of MAUDE data, with the peak single-year volume reaching 13,012 reports — trend shape can reflect shifts in device sales, FDA reporting requirements, or post-market recall activity as much as intrinsic device performance. The MAUDE system is one input among many in FDA post-market surveillance and does not draw safety conclusions from individual submissions. All figures reflect the openFDA snapshot refreshed on , and nothing on this page is medical or regulatory advice — consult a qualified clinician or the FDA for current safety communications.

108,834
Total Reports
2,440
Death Reports
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

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

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a manufacturer's products are unsafe — higher-volume manufacturers naturally generate more reports.