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2026 data FDA MAUDE openFDA FDA Class II

Pump, Breast, 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 §884.5160 (Obstetrics/Gynecology panel).

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FDA MAUDE casebook

openFDA event book Pump, Breast, Powered LIGHT-BOOK · MAUDE

#302 of 1000 · 5,556 reports · 1992–2026

  • BOOK 5,556 reports
  • RANK #302 of 1000
  • DEATH 2 death-typed
  • INJ 2,370 injury-typed
  • MALF 3,072 malfunction
  • SPAN 1992–2026
  • PEAK 2014: 1,036
  • PHOTO Suture

Nearest event-volume peer: Suture, Absorbable, Synthetic (29 report gap)

Pump, Breast, Powered sits #302 of 1000 among tracked device types with 5,556 MAUDE reports spanning 1992–2026. 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 run above the device-type norm

Pump, Breast, Powered carries 42.7% INJURY-coded reports, 12.4pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 42.7% corpus 30.3% · above corpus mean (+12.4 pp)
  • MALF 55.3% corpus 64.8% · below corpus mean (-9.5 pp)

Lead product-problem code Break is 18% of coded problems · Top event location is 67% of location-tagged rows .

Pump, Breast, Powered in the event-volume neighbourhood

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

reports

What this shows Pump, Breast, Powered carries 5,556 MAUDE reports, ranked #302 of 1000.

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

Event Types

Malfunction 3,072 (55.3%)
Injury 2,370 (42.7%)
Other 72 (1.3%)
40 (0.7%)
Death 2 (0.0%)

Patient Outcomes

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

3,389 (60.7%)
Other 2,074 (37.2%)
Required Intervention 50 (0.9%)
Hospitalization 23 (0.4%)
R 14 (0.3%)
O 9 (0.2%)
Disability 8 (0.1%)
Life Threatening 5 (0.1%)
S 3 (0.1%)
L 2 (0.0%)
Congenital Anomaly 2 (0.0%)
Death 2 (0.0%)
H 1 (0.0%)

Top Product Problems

Break 1,003
Decrease in Suction 766
Crack 586
Suction Problem 461
Sparking 321
Detachment Of Device Component 278
Material Separation 248
Patient Device Interaction Problem 233
Device Operates Differently Than Expected 219
Failure to Power Up 199
Insufficient Device Problem Information 188
Fluid/Blood Leak 173
Component Falling 171
Scratched Material 157
Adverse Event Without Identified Device or Use Problem 133
Noise, Audible 132
Overheating of Device 118
Protective Measures Problem 116
Smoking 109
Melted 100

Yearly Trend

92
1992: 1
96
1996: 1
97
1997: 7
99
1999: 5
00
2000: 6
01
2001: 7
02
2002: 9
03
2003: 2
04
2004: 1
05
2005: 10
06
2006: 4
07
2007: 2
08
2008: 2
10
2010: 88
11
2011: 240
12
2012: 685
13
2013: 837
14
2014: 1,036
15
2015: 496
16
2016: 373
17
2017: 437
18
2018: 291
19
2019: 168
20
2020: 168
21
2021: 119
22
2022: 154
23
2023: 200
24
2024: 118
25
2025: 70
26
2026: 19

Reports fell to 70 in 2025, down from an average of 159 in the two years before.

Related Entities for Pump, Breast, Powered

Event Locations

3,717 (66.9%)
I 1,729 (31.1%)
NO INFORMATION 45 (0.8%)
HOME 27 (0.5%)
HOSPITAL 17 (0.3%)
UNKNOWN 17 (0.3%)
OTHER 2 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)
PUBLIC VENUE 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Pump, Breast, Powered: 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 (5,556 here).

Suture, Absorbable, Synthetic 5,585 Prosthesis 5,649 Prosthesis 5,676 Compressor, Air, Portable 5,408

Similar death-typed counts

Nearest other device types by death-typed report count (2 here), distinct from the volume row.

Accessories, Catheter, G-U 2 Accessories, Soft Lens Products 2 Bed, Pediatric Open Hospital 2 Blade 2

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

Disclaimer: MAUDE figures for Pump, Breast, Powered 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 Pump, Breast, Powered; 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.