PHILIPS HEALTHCARE

FDA MAUDE device safety record · 2008–2025

What the Data Shows About PHILIPS HEALTHCARE

PHILIPS HEALTHCARE is associated with 4,684 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2008 through 2025. Of the total, 263 are coded as death reports and 508 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 HEALTHCARE 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 3,869 reports (82.6% of total). Patient-outcome categorizations are reported across 13 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 15 years of MAUDE data, with the peak single-year volume reaching 1,892 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.

4,684
Total Reports
263
Death Reports
508
Injury Reports
20
Device Types

Event Types

Malfunction 3,869 (82.6%)
Injury 508 (10.8%)
Death 263 (5.6%)
Other 34 (0.7%)
10 (0.2%)

Patient Outcomes

3,935 (83.6%)
Other 445 (9.5%)
Death 218 (4.6%)
Required Intervention 39 (0.8%)
Life Threatening 22 (0.5%)
Hospitalization 20 (0.4%)
R 8 (0.2%)
O 5 (0.1%)
S 4 (0.1%)
Disability 4 (0.1%)
D 2 (0.0%)
L 2 (0.0%)
H 1 (0.0%)

Yearly Trend

08
2008: 13
09
2009: 674
10
2010: 1,191
11
2011: 1,892
12
2012: 99
13
2013: 60
14
2014: 127
15
2015: 115
16
2016: 128
17
2017: 112
18
2018: 98
19
2019: 110
20
2020: 61
22
2022: 3
25
2025: 1

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.