PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

FDA MAUDE device safety record · 2008–2026

What the Data Shows About PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is associated with 33,114 adverse-event reports in the FDA Manufacturer and User Facility Device Experience (MAUDE) database , spanning reports dated from 2008 through 2026. Of the total, 35 are coded as death reports and 283 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 NEDERLAND B.V. should be reviewed at the device-family level rather than company-wide. Across those devices, 4 distinct event types appear in the record, led by Malfunction at 32,780 reports (99.0% of total). Patient-outcome categorizations are reported across 12 distinct outcomes, giving a shaped distribution rather than a single headline figure.

Year-over-year reporting volume is tracked across 17 years of MAUDE data, with the peak single-year volume reaching 15,146 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.

33,114
Total Reports
35
Death Reports
283
Injury Reports
20
Device Types

Event Types

Malfunction 32,780 (99.0%)
Injury 283 (0.9%)
Death 35 (0.1%)
Other 16 (0.0%)

Patient Outcomes

32,712 (98.6%)
Other 225 (0.7%)
Required Intervention 89 (0.3%)
Death 43 (0.1%)
R 36 (0.1%)
O 32 (0.1%)
L 15 (0.0%)
Life Threatening 13 (0.0%)
Hospitalization 12 (0.0%)
H 6 (0.0%)
D 3 (0.0%)
N 1 (0.0%)

Yearly Trend

08
2008: 21
09
2009: 3
10
2010: 4
11
2011: 1
13
2013: 3
14
2014: 13
15
2015: 2
17
2017: 1
18
2018: 1
19
2019: 7
20
2020: 52
21
2021: 302
22
2022: 1,883
23
2023: 7,236
24
2024: 7,416
25
2025: 15,146
26
2026: 1,023

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.