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2026 data FDA MAUDE openFDA FDA Class I

Device, Medical Examination, 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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §880.6320 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Device, Medical Examination, Ac Powered LIGHT-BOOK · MAUDE

#969 of 1000 · 401 reports · 1997–2026

  • BOOK 401 reports
  • RANK #969 of 1000
  • DEATH 0 death-typed
  • INJ 32 injury-typed
  • MALF 355 malfunction
  • SPAN 1997–2026
  • PEAK 2023: 83
  • PHOTO Enteral Specific Tran…

Nearest event-volume peer: Enteral Specific Transition Connectors (1 report gap)

Device, Medical Examination, Ac Powered sits #969 of 1000 among tracked device types with 401 MAUDE reports spanning 1997–2026. 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

Device, Medical Examination, Ac Powered carries 88.5% MALFUNCTION-coded reports, 23.7pp 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 8.0% corpus 30.3% · below corpus mean (-22.3 pp)
  • MALF 88.5% corpus 64.8% · above corpus mean (+23.7 pp)

Lead product-problem code Detachment of Device or Device Component is 35% of coded problems · Lead manufacturer MAQUET SAS accounts for 97% of manufacturer-tagged reports · Top event location is 64% of location-tagged rows .

Device, Medical Examination, Ac Powered in the event-volume neighbourhood

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

reports

What this shows Device, Medical Examination, Ac Powered carries 401 MAUDE reports, ranked #969 of 1000.

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

Event Types

Malfunction 355 (88.5%)
Injury 32 (8.0%)
Other 10 (2.5%)
4 (1.0%)

Patient Outcomes

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

359 (88.4%)
Other 26 (6.4%)
Required Intervention 11 (2.7%)
Hospitalization 3 (0.7%)
S 2 (0.5%)
Disability 2 (0.5%)
L 1 (0.2%)
O 1 (0.2%)
R 1 (0.2%)

Top Product Problems

Detachment of Device or Device Component 166
Crack 90
Break 54
Component Falling 25
Fracture 15
Melted 13
Device Fell 11
Fire 11
Unknown (for use when the device problem is not known) 11
Detachment Of Device Component 10
Smoking 10
Component Missing 8
Material Separation 8
Use of Device Problem 7
Material Split, Cut or Torn 6
Peeled/Delaminated 6
Sparking 6
Installation-Related Problem 5
Thermal Decomposition of Device 5
Component(s), broken 4

Yearly Trend

97
1997: 2
98
1998: 2
99
1999: 1
00
2000: 1
01
2001: 3
02
2002: 10
03
2003: 2
04
2004: 2
05
2005: 3
06
2006: 12
07
2007: 10
08
2008: 5
09
2009: 2
10
2010: 13
11
2011: 6
12
2012: 8
13
2013: 2
14
2014: 5
15
2015: 3
16
2016: 13
17
2017: 10
18
2018: 6
19
2019: 27
20
2020: 47
21
2021: 21
22
2022: 70
23
2023: 83
24
2024: 20
25
2025: 9
26
2026: 3

Reports fell to 9 in 2025, down from an average of 52 in the two years before.

Related Entities for Device, Medical Examination, Ac Powered

Top Manufacturers

MAQUET SAS 221
ALCON - IRVINE TECHNOLOGY CENTER 7

Event Locations

256 (63.8%)
I 113 (28.2%)
HOSPITAL 20 (5.0%)
NO INFORMATION 7 (1.7%)
AMBULATORY SURGICAL FACILITY 3 (0.7%)
OTHER 1 (0.2%)
UNKNOWN 1 (0.2%)

Compare MAQUET SAS vs ALCON - IRVINE TECHNOLOGY CENTER →

Nationwide devices with a comparable report-volume footprint

Device, Medical Examination, Ac Powered 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.

Similar report volume

Nearest other device types by FDA MAUDE report count (401 here).

Enteral Specific Transition Connectors 402 Bag 399 Diazo Colorimetry, Bilirubin 399 Methyl Methacrylate For Cranioplasty 403

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Device, Medical Examination, Ac 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 Device, Medical Examination, Ac 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.