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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#801 of 1000 · 616 reports · 1994–2026

  • BOOK 616 reports
  • RANK #801 of 1000
  • DEATH 22 death-typed
  • INJ 50 injury-typed
  • MALF 526 malfunction
  • SPAN 1994–2026
  • PEAK 2025: 248
  • PHOTO Nebulizer

Nearest event-volume peer: Nebulizer, Medicinal, Non-Ventilatory (Atomizer) (1 report gap)

System, Communication, Powered sits #801 of 1000 among tracked device types with 616 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 3.6% corpus 1.5% · above corpus mean (+2.1 pp)
  • INJ 8.1% corpus 30.4% · below corpus mean (-22.3 pp)
  • MALF 85.4% corpus 64.5% · above corpus mean (+20.9 pp)

Lead product-problem code Device Alarm System is 86% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 93% of manufacturer-tagged reports · Top event location is 86% 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 616 MAUDE reports, ranked #801 of 1000.

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

Event Types

Malfunction 526 (85.4%)
Injury 50 (8.1%)
Death 22 (3.6%)
11 (1.8%)
Other 7 (1.1%)

Patient Outcomes

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

519 (81.0%)
Other 33 (5.1%)
Death 22 (3.4%)
Hospitalization 18 (2.8%)
Required Intervention 12 (1.9%)
Life Threatening 11 (1.7%)
S 8 (1.2%)
R 7 (1.1%)
L 4 (0.6%)
O 4 (0.6%)
H 2 (0.3%)
Invalid Data 1 (0.2%)

Top Product Problems

Device Alarm System 424
No Audible Alarm 15
Defective Alarm 9
Use of Device Problem 6
Therapeutic or Diagnostic Output Failure 5
Communication or Transmission Problem 4
Product Quality Problem 4
Application Program Problem 3
Device Displays Incorrect Message 3
Activation Problem 2
Activation, Positioning or Separation Problem 2
Adverse Event Without Identified Device or Use Problem 2
Alarm Not Visible 2
Break 2
Computer Software Problem 2
Defective Device 2
Device Operates Differently Than Expected 2
Insufficient Information 2
Material Split, Cut or Torn 2
Self-Activation or Keying 2

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: 19

Related Entities for System, Communication, Powered

Top Manufacturers

BAXTER HEALTHCARE CORPORATION 175
HILL-ROM, INC. 14

Event Locations

527 (85.6%)
HOSPITAL 55 (8.9%)
I 13 (2.1%)
NO INFORMATION 8 (1.3%)
INVALID DATA 4 (0.6%)
HOME 3 (0.5%)
NURSING HOME 3 (0.5%)
OTHER 1 (0.2%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.2%)
UNKNOWN 1 (0.2%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Communication, Powered, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (616 here).

Nebulizer, Medicinal, Non-Ventilatory 615 Table 615 Container 614 Gram-Positive Bacteria And Their Resistance… 612

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 Extracorporeal System For Long-Term Respira… 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.