2026 data FDA MAUDE openFDA

Image-Intensified Fluoroscopic X-Ray System, Mobile

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.

FDA MAUDE casebook

openFDA event book Image-Intensified Fluoroscopic X-Ray System MID-BOOK · MAUDE

#202 of 1000 · 10,959 reports · 2012–2026

  • BOOK 10,959 reports
  • RANK #202 of 1000
  • DEATH 7 death-typed
  • INJ 272 injury-typed
  • MALF 10,670 malfunction
  • SPAN 2012–2026
  • PEAK 2016: 3,820
  • PHOTO Catheter

Nearest event-volume peer: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation (10 report gap)

Image-Intensified Fluoroscopic X-Ray System, Mobile sits #202 of 1000 among tracked device types with 10,959 MAUDE reports spanning 2012–2026. 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 0.1% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 2.5% corpus 30.4% · below corpus mean (-28.0 pp)
  • MALF 97.4% corpus 64.5% · above corpus mean (+32.9 pp)

Lead product-problem code Device Operates Differently Than Expected is 24% of coded problems · Lead manufacturer MEDTRONIC NAVIGATION, INC. (LITTLETON) accounts for 64% of manufacturer-tagged reports · Top event location I is 89% of location-tagged rows .

Image-Intensified Fluoroscopic X-Ray System in the event-volume neighbourhood

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

reports

What this shows Image-Intensified Fluoroscopic X-Ray System, Mobile carries 10,959 MAUDE reports, ranked #202 of 1000.

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

Event Types

Malfunction 10,670 (97.4%)
Injury 272 (2.5%)
Death 7 (0.1%)
4 (0.0%)
No answer provided 3 (0.0%)
Other 3 (0.0%)

Patient Outcomes

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

10,651 (96.8%)
Required Intervention 195 (1.8%)
Other 77 (0.7%)
R 23 (0.2%)
Hospitalization 22 (0.2%)
H 14 (0.1%)
Death 6 (0.1%)
O 5 (0.0%)
S 5 (0.0%)
Disability 2 (0.0%)
Life Threatening 2 (0.0%)
D 1 (0.0%)
L 1 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Device Operates Differently Than Expected 3,430
Electrical /Electronic Property Problem 1,832
Application Program Freezes, Becomes Nonfunctional 1,768
Device Displays Incorrect Message 1,141
Communication or Transmission Problem 1,079
Device Inoperable 1,072
Computer Software Problem 500
Poor Quality Image 402
Positioning Problem 383
Difficult to Open or Close 378
Mechanical Problem 348
Unexpected Shutdown 269
Failure to Run on Battery 257
Device Stops Intermittently 249
Material Deformation 247
Failure to Power Up 236
Application Interface Becomes Non-Functional Or Program Exits Abnormally 223
Adverse Event Without Identified Device or Use Problem 220
Imprecision 215
Noise, Audible 201

Yearly Trend

12
2012: 5
13
2013: 41
14
2014: 89
15
2015: 97
16
2016: 3,820
17
2017: 1,697
18
2018: 1,647
19
2019: 1,297
20
2020: 816
21
2021: 554
22
2022: 295
23
2023: 275
24
2024: 192
25
2025: 124
26
2026: 10

Related Entities for Image-Intensified Fluoroscopic X-Ray System, Mobile

Event Locations

I 9,765 (89.1%)
1,153 (10.5%)
HOSPITAL 33 (0.3%)
NO INFORMATION 8 (0.1%)

Compare MEDTRONIC NAVIGATION, INC. (LITTLETON) vs MEDTRONIC NAVIGATION, INC (LITTLETON) →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Image-Intensified Fluoroscopic X-Ray System, 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 (10,959 here).

Similar death-typed counts

Nearest other device types by death-typed report count (7 here), distinct from the volume row.

Disclaimer: MAUDE figures for Image-Intensified Fluoroscopic X-Ray System 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 Image-Intensified Fluoroscopic X-Ray System; 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.