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2026 data FDA MAUDE openFDA FDA Class II

Subsystem, Water Purification

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 §876.5665 (Gastroenterology, Urology panel).

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FDA MAUDE casebook

openFDA event book Subsystem, Water Purification LIGHT-BOOK · MAUDE

#780 of 1000 · 696 reports · 1993–2026

  • BOOK 696 reports
  • RANK #780 of 1000
  • DEATH 9 death-typed
  • INJ 40 injury-typed
  • MALF 606 malfunction
  • SPAN 1993–2026
  • PEAK 2024: 174
  • PHOTO Endoscope

Nearest event-volume peer: Endoscope, Ac-Powered And Accessories (1 report gap)

Subsystem, Water Purification sits #780 of 1000 among tracked device types with 696 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 →

Injury-coded reports sit below the device-type norm

Subsystem, Water Purification carries 5.7% INJURY-coded reports, 24.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.3% corpus 1.5% · near corpus mean (-0.2 pp)
  • INJ 5.7% corpus 30.3% · below corpus mean (-24.5 pp)
  • MALF 87.1% corpus 64.8% · above corpus mean (+22.2 pp)

Lead product-problem code Thermal Decomposition of Device is 42% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 67% of manufacturer-tagged reports · Top event location is 83% of location-tagged rows .

Subsystem, Water Purification in the event-volume neighbourhood

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

reports

What this shows Subsystem, Water Purification carries 696 MAUDE reports, ranked #780 of 1000.

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

Event Types

Malfunction 606 (87.1%)
Injury 40 (5.7%)
25 (3.6%)
Other 16 (2.3%)
Death 9 (1.3%)

Patient Outcomes

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

627 (89.1%)
Other 30 (4.3%)
Required Intervention 15 (2.1%)
Death 9 (1.3%)
Hospitalization 9 (1.3%)
Life Threatening 7 (1.0%)
H 3 (0.4%)
R 2 (0.3%)
O 1 (0.1%)
Disability 1 (0.1%)

Top Product Problems

Thermal Decomposition of Device 313
Fluid/Blood Leak 186
Melted 43
Sparking 24
Break 23
Nonstandard Device 23
Microbial Contamination of Device 22
Arcing 19
Smoking 19
Device Operates Differently Than Expected 13
Contamination 10
Device Displays Incorrect Message 9
Device Alarm System 7
Device Emits Odor 7
Other (for use when an appropriate device code cannot be identified) 7
Crack 6
Design/structure problem 6
Fire 6
Adverse Event Without Identified Device or Use Problem 5
Defective Device 5

Yearly Trend

93
1993: 1
94
1994: 2
96
1996: 1
97
1997: 1
98
1998: 1
99
1999: 1
00
2000: 16
01
2001: 2
02
2002: 8
03
2003: 4
04
2004: 3
05
2005: 3
06
2006: 4
07
2007: 1
08
2008: 5
10
2010: 12
11
2011: 4
12
2012: 4
13
2013: 41
14
2014: 34
15
2015: 12
16
2016: 3
17
2017: 6
18
2018: 3
19
2019: 13
20
2020: 12
21
2021: 35
22
2022: 57
23
2023: 140
24
2024: 174
25
2025: 77
26
2026: 16

Reports fell to 77 in 2025, down from an average of 157 in the two years before.

Related Entities for Subsystem, Water Purification

Top Manufacturers

BAXTER HEALTHCARE CORPORATION 121
VANTIVE US HEALTHCARE LLC 52
BAXTER HEALTHCARE CORP. 4
BAXTER HEALTHCARE - LARGO 3

Event Locations

580 (83.3%)
I 65 (9.3%)
HOSPITAL 23 (3.3%)
OUTPATIENT TREATMENT FACILITY 16 (2.3%)
NO INFORMATION 7 (1.0%)
DIALYSIS CENTER 1 (0.1%)
DIALYSIS UNIT 1 (0.1%)
OTHER 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare BAXTER HEALTHCARE CORPORATION vs VANTIVE US HEALTHCARE LLC →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Subsystem, Water Purification: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (696 here).

Endoscope, Ac-Powered And Accessories 697 Endoscopic Cytology Brush 695 Accessories, Photographic, For Endoscope 698 Lectins And Protectins 701

Similar death-typed counts

Nearest other device types by death-typed report count (9 here), distinct from the volume row.

Blood Establishment Computer Software And A… 9 Catheter, Conduction, Anesthetic 9 Choledochoscope And Accessories 9 Connector, Airway 9

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

Disclaimer: MAUDE figures for Subsystem, Water Purification 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 Subsystem, Water Purification; 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.