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2026 data FDA MAUDE openFDA

System, Imaging, Pulsed Echo, 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 Echo, Ultrasonic LIGHT-BOOK · MAUDE

#277 of 1000 · 6,335 reports · 1993–2026

  • BOOK 6,335 reports
  • RANK #277 of 1000
  • DEATH 17 death-typed
  • INJ 236 injury-typed
  • MALF 6,031 malfunction
  • SPAN 1993–2026
  • PEAK 2024: 640
  • PHOTO Percutaneous Cardiac…

Nearest event-volume peer: Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation (13 report gap)

System, Imaging, Pulsed Echo, Ultrasonic sits #277 of 1000 among tracked device types with 6,335 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 0.3% corpus 1.5% · below corpus mean (-1.3 pp)
  • INJ 3.7% corpus 30.4% · below corpus mean (-26.7 pp)
  • MALF 95.2% corpus 64.5% · above corpus mean (+30.7 pp)

Lead product-problem code Poor Quality Image is 31% of coded problems · Lead manufacturer C.R. BARD, INC. (BASD) -3006260740 accounts for 73% of manufacturer-tagged reports · Top event location is 56% of location-tagged rows .

System, Imaging, Pulsed Echo, 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 Echo, Ultrasonic carries 6,335 MAUDE reports, ranked #277 of 1000.

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

Event Types

Malfunction 6,031 (95.2%)
Injury 236 (3.7%)
Other 42 (0.7%)
Death 17 (0.3%)
9 (0.1%)

Patient Outcomes

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

Other 3,156 (49.7%)
3,029 (47.7%)
Required Intervention 93 (1.5%)
Hospitalization 17 (0.3%)
Death 15 (0.2%)
R 14 (0.2%)
O 7 (0.1%)
Disability 7 (0.1%)
L 6 (0.1%)
Life Threatening 5 (0.1%)
H 2 (0.0%)
Congenital Anomaly 2 (0.0%)
S 1 (0.0%)

Top Product Problems

Poor Quality Image 1,653
No Apparent Adverse Event 640
Defective Component 490
Battery Problem 357
Loss of Power 340
Unexpected Shutdown 320
Retraction Problem 317
Break 301
Application Program Freezes, Becomes Nonfunctional 241
No Display/Image 124
Data Problem 106
Sharp Edges 99
Contamination /Decontamination Problem 87
Image Display Error/Artifact 76
Loss of Data 45
Premature Discharge of Battery 45
Charging Problem 43
Computer Software Problem 43
Difficult or Delayed Activation 42
Device Operates Differently Than Expected 39

Yearly Trend

93
1993: 1
95
1995: 1
96
1996: 7
97
1997: 25
98
1998: 6
99
1999: 17
00
2000: 25
01
2001: 244
02
2002: 20
03
2003: 13
04
2004: 5
05
2005: 7
06
2006: 7
07
2007: 39
08
2008: 20
09
2009: 27
10
2010: 20
11
2011: 58
12
2012: 78
13
2013: 436
14
2014: 304
15
2015: 268
16
2016: 254
17
2017: 238
18
2018: 368
19
2019: 537
20
2020: 498
21
2021: 617
22
2022: 511
23
2023: 527
24
2024: 640
25
2025: 477
26
2026: 40

Related Entities for System, Imaging, Pulsed Echo, Ultrasonic

Top Manufacturers

C.R. BARD, INC. (BASD) -3006260740 2,351
BARD ACCESS SYSTEMS 758
ALCON - IRVINE TECHNOLOGY CENTER 123

Event Locations

3,556 (56.1%)
HOSPITAL 1,432 (22.6%)
I 1,213 (19.1%)
OUTPATIENT DIAGNOSTIC FACILITY 55 (0.9%)
OTHER 20 (0.3%)
NO INFORMATION 17 (0.3%)
OUTPATIENT TREATMENT FACILITY 12 (0.2%)
UNKNOWN 11 (0.2%)
AMBULATORY SURGICAL FACILITY 7 (0.1%)
NOT APPLICABLE 5 (0.1%)
HOME 4 (0.1%)
INVALID DATA 2 (0.0%)
NURSING HOME 1 (0.0%)

Compare C.R. BARD, INC. (BASD) -3006260740 vs BARD ACCESS SYSTEMS →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Imaging, Pulsed Echo, 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 (6,335 here).

Percutaneous Cardiac Ablation Catheter For… 6,348 Prosthesis 6,304 Device, Thermal Ablation, Endometrial 6,244 Hearing Aid, Bone Conduction, Implanted 6,463

Similar death-typed counts

Nearest other device types by death-typed report count (17 here), distinct from the volume row.

Accessories, Blood Circuit, Hemodialysis 17 Agent, Occluding, Vascular, Permanent 17 Cable, Transducer And Electrode, Patient, 17 Cardiovascular Procedure Kit 17

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

Disclaimer: MAUDE figures for System, Imaging, Pulsed Echo, 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 Echo, 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.