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2026 data FDA MAUDE openFDA FDA Class II

Negative Pressure Wound Therapy Powered Suction Pump

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).

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FDA MAUDE casebook

openFDA event book Negative Pressure Wound Therapy Powered Suc… LIGHT-BOOK · MAUDE

#229 of 1000 · 9,164 reports · 2007–2026

  • BOOK 9,164 reports
  • RANK #229 of 1000
  • DEATH 75 death-typed
  • INJ 3,272 injury-typed
  • MALF 5,787 malfunction
  • SPAN 2007–2026
  • PEAK 2020: 3,664
  • PHOTO Controller

Nearest event-volume peer: Controller, Temperature, Cardiopulmonary Bypass (1 report gap)

Negative Pressure Wound Therapy Powered Suction Pump sits #229 of 1000 among tracked device types with 9,164 MAUDE reports spanning 2007–2026. 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 run above the device-type norm

Negative Pressure Wound Therapy Powered Suc… carries 35.7% INJURY-coded reports, 5.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.8% corpus 1.5% · below corpus mean (-0.7 pp)
  • INJ 35.7% corpus 30.3% · above corpus mean (+5.4 pp)
  • MALF 63.1% corpus 64.8% · below corpus mean (-1.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 18% of coded problems · Lead manufacturer SMITH & NEPHEW MEDICAL LTD. accounts for 94% of manufacturer-tagged reports · Top event location I is 79% of location-tagged rows .

Negative Pressure Wound Therapy Powered Suc… in the event-volume neighbourhood

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

reports

What this shows Negative Pressure Wound Therapy Powered Suction Pump carries 9,164 MAUDE reports, ranked #229 of 1000.

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

Event Types

Malfunction 5,787 (63.1%)
Injury 3,272 (35.7%)
Death 75 (0.8%)
22 (0.2%)
Other 8 (0.1%)

Patient Outcomes

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

5,680 (55.6%)
Required Intervention 1,581 (15.5%)
Other 970 (9.5%)
Hospitalization 785 (7.7%)
R 757 (7.4%)
O 173 (1.7%)
Death 79 (0.8%)
H 77 (0.8%)
S 44 (0.4%)
Disability 30 (0.3%)
Life Threatening 21 (0.2%)
L 17 (0.2%)
Congenital Anomaly 6 (0.1%)
D 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 1,534
Collapse 1,148
Insufficient Device Problem Information 900
Failure to Charge 729
Suction Failure 663
Pumping Stopped 603
False Alarm 531
Device Alarm System 364
Defective Alarm 342
Improper or Incorrect Procedure or Method 300
Obstruction of Flow 256
Unexpected Shutdown 219
Leak/Splash 188
Suction Problem 180
Device Operates Differently Than Expected 151
Appropriate Device Problem Term/Code Not Available 144
Overheating of Device 130
Failure to Power Up 116
Protective Measures Problem 109
Defective Device 94

Yearly Trend

07
2007: 1
08
2008: 1
09
2009: 79
10
2010: 80
11
2011: 130
12
2012: 97
13
2013: 169
14
2014: 229
15
2015: 378
16
2016: 398
17
2017: 368
18
2018: 422
19
2019: 994
20
2020: 3,664
21
2021: 1,422
22
2022: 258
23
2023: 143
24
2024: 135
25
2025: 143
26
2026: 53

Reports in 2025 (143) held close to the prior two-year average of 139.

Related Entities for Negative Pressure Wound Therapy Powered Suction Pump

Top Manufacturers

SMITH & NEPHEW MEDICAL LTD. 5,069
SMITH & NEPHEW, INC. 331

Event Locations

I 7,206 (78.6%)
1,784 (19.5%)
HOSPITAL 102 (1.1%)
NO INFORMATION 52 (0.6%)
OUTPATIENT TREATMENT FACILITY 9 (0.1%)
HOME 6 (0.1%)
OTHER 4 (0.0%)
NURSING HOME 1 (0.0%)

Compare SMITH & NEPHEW MEDICAL LTD. vs SMITH & NEPHEW, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Negative Pressure Wound Therapy Powered Suc…: 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 (9,164 here).

Controller 9,165 Intervertebral Fusion Device With Bone Graft 9,183 Catheter, Retention Type, Balloon 9,331 Percutaneous Cardiac Ablation Catheter For… 8,981

Similar death-typed counts

Nearest other device types by death-typed report count (75 here), distinct from the volume row.

Lift, Patient, Ac-Powered 75 Prosthesis 75 Screw, Fixation, Bone 75 Intestinal Stimulator 74

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

Disclaimer: MAUDE figures for Negative Pressure Wound Therapy Powered Suc… 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 Negative Pressure Wound Therapy Powered Suc…; 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.