2026 data FDA MAUDE openFDA FDA Class II

Apparatus, Suction, Ward Use, Portable, Ac-Powered

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 §878.4780 (General, Plastic Surgery panel).

FDA MAUDE casebook

openFDA event book Apparatus LIGHT-BOOK · MAUDE

#499 of 1000 · 2,026 reports · 1994–2026

  • BOOK 2,026 reports
  • RANK #499 of 1000
  • DEATH 53 death-typed
  • INJ 277 injury-typed
  • MALF 1,651 malfunction
  • SPAN 1994–2026
  • PEAK 2021: 227
  • PHOTO Tricuspid Valve Repai…

Nearest event-volume peer: Tricuspid Valve Repair Device, Percutaneously Delivered (2 report gap)

Apparatus, Suction, Ward Use, Portable, Ac-Powered sits #499 of 1000 among tracked device types with 2,026 MAUDE reports spanning 1994–2026. 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 →

Malfunction reports run above the device-type norm

Apparatus carries 81.5% MALFUNCTION-coded reports, 16.7pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.6% corpus 1.5% · above corpus mean (+1.1 pp)
  • INJ 13.7% corpus 30.3% · below corpus mean (-16.6 pp)
  • MALF 81.5% corpus 64.8% · above corpus mean (+16.7 pp)

Lead product-problem code Suction Problem is 13% of coded problems · Lead manufacturer STRYKER INSTRUMENTS-KALAMAZOO accounts for 42% of manufacturer-tagged reports · Top event location is 52% of location-tagged rows .

Apparatus in the event-volume neighbourhood

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

reports

What this shows Apparatus, Suction, Ward Use, Portable, Ac-Powered carries 2,026 MAUDE reports, ranked #499 of 1000.

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

Event Types

Malfunction 1,651 (81.5%)
Injury 277 (13.7%)
Death 53 (2.6%)
Other 37 (1.8%)
8 (0.4%)

Patient Outcomes

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

1,605 (76.6%)
Required Intervention 161 (7.7%)
Other 118 (5.6%)
Hospitalization 71 (3.4%)
R 57 (2.7%)
Death 55 (2.6%)
Life Threatening 10 (0.5%)
S 8 (0.4%)
O 3 (0.1%)
Disability 3 (0.1%)
H 2 (0.1%)
L 2 (0.1%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Suction Problem 215
Smoking 157
Inadequate Filtration Process 132
Device Emits Odor 119
Failure to Power Up 118
Unknown (for use when the device problem is not known) 118
Suction Failure 87
Thermal Decomposition of Device 78
Fluid/Blood Leak 66
Electrical /Electronic Property Problem 61
Filtration Problem 60
Material Frayed 60
Overheating of Device 54
Complete Blockage 53
Device Operates Differently Than Expected 53
Incorrect Measurement 52
Melted 48
Sparking 46
No Pressure 45
Aspiration Issue 39

Yearly Trend

94
1994: 1
95
1995: 2
96
1996: 8
97
1997: 7
98
1998: 6
99
1999: 6
00
2000: 13
01
2001: 6
02
2002: 9
03
2003: 3
04
2004: 24
05
2005: 69
06
2006: 53
07
2007: 48
08
2008: 57
09
2009: 34
10
2010: 7
11
2011: 9
12
2012: 18
13
2013: 12
14
2014: 68
15
2015: 118
16
2016: 119
17
2017: 102
18
2018: 170
19
2019: 132
20
2020: 89
21
2021: 227
22
2022: 215
23
2023: 187
24
2024: 103
25
2025: 46
26
2026: 58

Reports fell to 46 in 2025, down from an average of 145 in the two years before.

Related Entities for Apparatus, Suction, Ward Use, Portable, Ac-Powered

Event Locations

1,052 (51.9%)
I 837 (41.3%)
HOSPITAL 102 (5.0%)
HOME 7 (0.3%)
NO INFORMATION 6 (0.3%)
NOT APPLICABLE 6 (0.3%)
INVALID DATA 4 (0.2%)
OUTPATIENT TREATMENT FACILITY 3 (0.1%)
UNKNOWN 3 (0.1%)
NURSING HOME 2 (0.1%)
OTHER 2 (0.1%)
IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.0%)
LONG-TERM CARE FACILITY 1 (0.0%)

Compare STRYKER INSTRUMENTS-KALAMAZOO vs PENUMBRA, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Apparatus: 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 (2,026 here).

Similar death-typed counts

Nearest other device types by death-typed report count (53 here), distinct from the volume row.

Disclaimer: MAUDE figures for Apparatus 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 Apparatus; 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.