2026 data FDA MAUDE openFDA FDA Class II

Disinfector, Medical Devices

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 Class II (moderate risk, special controls required), regulated under 21 CFR §880.6992 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Disinfector, Medical Devices LIGHT-BOOK · MAUDE

#601 of 1000 · 1,315 reports · 1999–2026

  • BOOK 1,315 reports
  • RANK #601 of 1000
  • DEATH 0 death-typed
  • INJ 78 injury-typed
  • MALF 784 malfunction
  • SPAN 1999–2026
  • PEAK 2013: 151
  • PHOTO Pump

Nearest event-volume peer: Pump, Air, Non-Manual, For Endoscope (1 report gap)

Disinfector, Medical Devices sits #601 of 1000 among tracked device types with 1,315 MAUDE reports spanning 1999–2026. 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 → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Disinfector, Medical Devices carries 5.9% INJURY-coded reports, 24.4pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 5.9% corpus 30.3% · below corpus mean (-24.4 pp)
  • MALF 59.6% corpus 64.8% · below corpus mean (-5.2 pp)

Lead product-problem code Leak/Splash is 21% of coded problems · Top event location is 59% of location-tagged rows .

Disinfector, Medical Devices in the event-volume neighbourhood

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

reports

What this shows Disinfector, Medical Devices carries 1,315 MAUDE reports, ranked #601 of 1000.

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

Event Types

Malfunction 784 (59.6%)
449 (34.1%)
Injury 78 (5.9%)
Other 4 (0.3%)

Patient Outcomes

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

1,045 (79.8%)
Other 240 (18.3%)
Required Intervention 19 (1.5%)
Hospitalization 3 (0.2%)
S 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Leak/Splash 249
Fluid/Blood Leak 220
Adverse Event Without Identified Device or Use Problem 74
Fire 74
Detachment of Device or Device Component 71
Smoking 63
Insufficient Device Problem Information 54
Use of Device Problem 51
Improper or Incorrect Procedure or Method 48
Device Fell 42
Device Operates Differently Than Expected 41
Component Falling 40
Mechanical Jam 40
Device Emits Odor 36
Device Handling Problem 22
Device Displays Incorrect Message 21
Break 20
Overheating of Device 20
Device Dislodged or Dislocated 14
Difficult to Open or Close 14

Yearly Trend

99
1999: 1
01
2001: 1
03
2003: 1
05
2005: 2
07
2007: 1
08
2008: 4
09
2009: 11
10
2010: 18
11
2011: 18
12
2012: 58
13
2013: 151
14
2014: 92
15
2015: 82
16
2016: 80
17
2017: 97
18
2018: 73
19
2019: 78
20
2020: 80
21
2021: 93
22
2022: 85
23
2023: 79
24
2024: 78
25
2025: 77
26
2026: 55

Reports in 2025 (77) held close to the prior two-year average of 79.

Related Entities for Disinfector, Medical Devices

Event Locations

780 (59.3%)
I 426 (32.4%)
HOSPITAL 94 (7.1%)
NO INFORMATION 8 (0.6%)
OTHER 4 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Nationwide devices with a comparable report-volume footprint

Disinfector, Medical Devices carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Disclaimer: MAUDE figures for Disinfector, Medical Devices 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 Disinfector, Medical Devices; 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.