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2026 data FDA MAUDE openFDA FDA Class II

System, Communication, 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 §890.3710 (Physical Medicine panel).

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FDA MAUDE casebook

openFDA event book System, Communication, Powered LIGHT-BOOK · MAUDE

#772 of 1000 · 714 reports · 1994–2026

  • BOOK 714 reports
  • RANK #772 of 1000
  • DEATH 22 death-typed
  • INJ 51 injury-typed
  • MALF 623 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 248
  • PHOTO Radioimmunoassay

Nearest event-volume peer: Radioimmunoassay, Estradiol (5 report gap)

System, Communication, Powered sits #772 of 1000 among tracked device types with 714 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 →

Injury-coded reports sit below the device-type norm

System, Communication, Powered carries 7.1% INJURY-coded reports, 23.1pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.1% corpus 1.5% · above corpus mean (+1.6 pp)
  • INJ 7.1% corpus 30.3% · below corpus mean (-23.1 pp)
  • MALF 87.3% corpus 64.8% · above corpus mean (+22.4 pp)

Lead product-problem code Device Alarm System is 81% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 95% of manufacturer-tagged reports · Top event location is 88% of location-tagged rows .

System, Communication, Powered in the event-volume neighbourhood

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

reports

What this shows System, Communication, Powered carries 714 MAUDE reports, ranked #772 of 1000.

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

Event Types

Malfunction 623 (87.3%)
Injury 51 (7.1%)
Death 22 (3.1%)
11 (1.5%)
Other 7 (1.0%)

Patient Outcomes

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

600 (82.9%)
Other 34 (4.7%)
Death 22 (3.0%)
Hospitalization 19 (2.6%)
Required Intervention 12 (1.7%)
Life Threatening 11 (1.5%)
S 8 (1.1%)
R 7 (1.0%)
L 4 (0.6%)
O 4 (0.6%)
H 2 (0.3%)
Invalid Data 1 (0.1%)

Top Product Problems

Device Alarm System 556
No Audible Alarm 24
Device Operates Differently Than Expected 12
Defective Alarm 11
Communication or Transmission Problem 9
Device Inoperable 8
Smoking 8
Use of Device Problem 8
Computer Software Problem 5
Overheating of Device 5
Product Quality Problem 5
Therapeutic or Diagnostic Output Failure 5
Application Program Problem 4
Disconnection 4
Entrapment of Device 4
Improper or Incorrect Procedure or Method 4
Melted 4
Adverse Event Without Identified Device or Use Problem 3
Component(s), broken 3
Defective Device 3

Yearly Trend

94
1994: 3
95
1995: 5
96
1996: 4
97
1997: 1
98
1998: 1
99
1999: 1
00
2000: 3
01
2001: 3
04
2004: 2
05
2005: 6
06
2006: 2
07
2007: 4
08
2008: 7
09
2009: 5
10
2010: 14
11
2011: 16
12
2012: 13
13
2013: 14
14
2014: 12
16
2016: 4
17
2017: 7
18
2018: 7
19
2019: 2
20
2020: 2
21
2021: 5
22
2022: 27
23
2023: 74
24
2024: 105
25
2025: 248
26
2026: 117

Reports rose to 248 in 2025, up from an average of 90 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for System, Communication, Powered

Top Manufacturers

BAXTER HEALTHCARE CORPORATION 271
HILL-ROM, INC. 14

Event Locations

625 (87.5%)
HOSPITAL 55 (7.7%)
I 13 (1.8%)
NO INFORMATION 8 (1.1%)
INVALID DATA 4 (0.6%)
HOME 3 (0.4%)
NURSING HOME 3 (0.4%)
OTHER 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
UNKNOWN 1 (0.1%)

Compare BAXTER HEALTHCARE CORPORATION vs HILL-ROM, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Communication, 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 (714 here).

Radioimmunoassay, Estradiol 719 Apparatus, Exhaust, Surgical 720 Oximeter, Tissue Saturation 706 Humidifier Nebulizer Kit 723

Similar death-typed counts

Nearest other device types by death-typed report count (22 here), distinct from the volume row.

Accessories, Cleaning, For Endoscope 22 Charger, Pacemaker 22 Device, Thermal Ablation, Endometrial 22 Endoscopic Access Overtube 22

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

Disclaimer: MAUDE figures for System, Communication, 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 System, Communication, 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.