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2026 data FDA MAUDE openFDA

System, Imaging, Pulsed Doppler, Ultrasonic

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book System, Imaging, Pulsed Doppler, Ultrasonic LIGHT-BOOK · MAUDE

#443 of 1000 · 2,413 reports · 1993–2026

  • BOOK 2,413 reports
  • RANK #443 of 1000
  • DEATH 33 death-typed
  • INJ 233 injury-typed
  • MALF 2,110 malfunction
  • SPAN 1993–2026
  • PEAK 2025: 621
  • PHOTO Mattress

Nearest event-volume peer: Mattress, Air Flotation, Alternating Pressure (4 report gap)

System, Imaging, Pulsed Doppler, Ultrasonic sits #443 of 1000 among tracked device types with 2,413 MAUDE reports spanning 1993–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 1.4% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 9.7% corpus 30.4% · below corpus mean (-20.8 pp)
  • MALF 87.4% corpus 64.5% · above corpus mean (+22.9 pp)

Lead product-problem code Unintended System Motion is 27% of coded problems · Lead manufacturer PHILIPS NORTH AMERICA LLC accounts for 100% of manufacturer-tagged reports · Top event location is 68% of location-tagged rows .

System, Imaging, Pulsed Doppler, Ultrasonic in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows System, Imaging, Pulsed Doppler, Ultrasonic carries 2,413 MAUDE reports, ranked #443 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 2,110 (87.4%)
Injury 233 (9.7%)
Death 33 (1.4%)
Other 27 (1.1%)
10 (0.4%)

Patient Outcomes

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

2,021 (82.0%)
Other 184 (7.5%)
Required Intervention 95 (3.9%)
Hospitalization 65 (2.6%)
Death 30 (1.2%)
H 23 (0.9%)
R 21 (0.9%)
D 5 (0.2%)
L 4 (0.2%)
O 4 (0.2%)
S 4 (0.2%)
Disability 4 (0.2%)
Life Threatening 4 (0.2%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Unintended System Motion 441
Application Program Freezes, Becomes Nonfunctional 134
Material Integrity Problem 115
Adverse Event Without Identified Device or Use Problem 103
Poor Quality Image 74
Mechanical Jam 73
No Display/Image 72
Device Operational Issue 70
Loss of Data 66
Patient Data Problem 64
Electrical /Electronic Property Problem 50
Unintended Application Program Shut Down 50
Device Operates Differently Than Expected 40
Detachment of Device or Device Component 39
Fire 38
Material Split, Cut or Torn 38
Unexpected Shutdown 38
Data Problem 34
Material Separation 34
Break 32

Yearly Trend

93
1993: 1
95
1995: 2
96
1996: 2
97
1997: 5
98
1998: 7
99
1999: 4
00
2000: 4
01
2001: 8
02
2002: 8
03
2003: 8
04
2004: 2
05
2005: 5
06
2006: 5
07
2007: 3
08
2008: 2
09
2009: 9
10
2010: 17
11
2011: 18
12
2012: 20
13
2013: 18
14
2014: 48
15
2015: 116
16
2016: 145
17
2017: 146
18
2018: 85
19
2019: 59
20
2020: 67
21
2021: 213
22
2022: 186
23
2023: 229
24
2024: 266
25
2025: 621
26
2026: 84

Related Entities for System, Imaging, Pulsed Doppler, Ultrasonic

Top Manufacturers

PHILIPS NORTH AMERICA LLC 35

Event Locations

1,633 (67.7%)
I 520 (21.5%)
HOSPITAL 205 (8.5%)
NO INFORMATION 27 (1.1%)
OUTPATIENT DIAGNOSTIC FACILITY 16 (0.7%)
OTHER 5 (0.2%)
INVALID DATA 2 (0.1%)
UNKNOWN 2 (0.1%)
HOME 1 (0.0%)
NOT APPLICABLE 1 (0.0%)
OUTPATIENT TREATMENT FACILITY 1 (0.0%)

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Imaging, Pulsed Doppler, Ultrasonic, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (2,413 here).

Mattress 2,417 Staple, Fixation, Bone 2,423 Stylet For Catheter, Gastro-Urology 2,398 Tube, Bronchial 2,398

Similar death-typed counts

Nearest other device types by death-typed report count (33 here), distinct from the volume row.

Bed, Air Fluidized 33 Catheter, Umbilical Artery 33 Electrocardiograph 33 Glucose Dehydrogenase, Glucose 33

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

Disclaimer: MAUDE figures for System, Imaging, Pulsed Doppler, Ultrasonic are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for System, Imaging, Pulsed Doppler, Ultrasonic; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.