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2026 data FDA MAUDE openFDA FDA Class II

Dc-Defibrillator, Low-Energy, (Including Paddles)

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 §870.5300 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Dc-Defibrillator, Low-Energy, MID-BOOK · MAUDE

#163 of 1000 · 16,579 reports · 1993–2026

  • BOOK 16,579 reports
  • RANK #163 of 1000
  • DEATH 943 death-typed
  • INJ 444 injury-typed
  • MALF 14,791 malfunction
  • SPAN 1993–2026
  • PEAK 1999: 1,291
  • PHOTO Applier

Nearest event-volume peer: Applier, Surgical, Clip (32 report gap)

Dc-Defibrillator, Low-Energy, (Including Paddles) sits #163 of 1000 among tracked device types with 16,579 MAUDE reports spanning 1993–2026. 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

Dc-Defibrillator, Low-Energy, carries 2.7% INJURY-coded reports, 27.6pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 5.7% corpus 1.5% · above corpus mean (+4.2 pp)
  • INJ 2.7% corpus 30.3% · below corpus mean (-27.6 pp)
  • MALF 89.2% corpus 64.8% · above corpus mean (+24.4 pp)

Lead product-problem code Device Displays Incorrect Message is 12% of coded problems · Lead manufacturer ZOLL MEDICAL CORP. accounts for 29% of manufacturer-tagged reports · Top event location is 39% of location-tagged rows .

Dc-Defibrillator, Low-Energy, in the event-volume neighbourhood

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

reports

What this shows Dc-Defibrillator, Low-Energy, (Including Paddles) carries 16,579 MAUDE reports, ranked #163 of 1000.

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

Event Types

Malfunction 14,791 (89.2%)
Death 943 (5.7%)
Injury 444 (2.7%)
Other 306 (1.8%)
95 (0.6%)

Patient Outcomes

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

10,658 (63.5%)
Other 4,581 (27.3%)
Death 948 (5.7%)
Life Threatening 266 (1.6%)
Required Intervention 79 (0.5%)
R 71 (0.4%)
O 56 (0.3%)
Hospitalization 51 (0.3%)
L 44 (0.3%)
S 8 (0.0%)
Invalid Data 4 (0.0%)
Disability 3 (0.0%)
D 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Top Product Problems

Device Displays Incorrect Message 2,038
Replace 1,901
Failure to Charge 1,426
Failure to Power Up 1,376
Failure to Discharge 1,278
Pacing Problem 1,092
No Display/Image 1,056
Failure To Run On AC/DC 1,022
Failure to Deliver Energy 972
Device Inoperable 918
Loss of Power 789
Defibrillation/Stimulation Problem 549
Device Issue 528
Other (for use when an appropriate device code cannot be identified) 494
Display or Visual Feedback Problem 461
Failure, intermittent 436
Blank screen 306
Signal Artifact/Noise 254
Energy Output Problem 222
No Pacing 212

Yearly Trend

93
1993: 38
94
1994: 106
95
1995: 108
96
1996: 393
97
1997: 953
98
1998: 1,285
99
1999: 1,291
00
2000: 1,210
01
2001: 1,112
02
2002: 877
03
2003: 775
04
2004: 681
05
2005: 852
06
2006: 671
07
2007: 550
08
2008: 1,215
09
2009: 1,056
10
2010: 635
11
2011: 386
12
2012: 398
13
2013: 602
14
2014: 481
15
2015: 86
16
2016: 58
17
2017: 49
18
2018: 28
19
2019: 34
20
2020: 19
21
2021: 22
22
2022: 80
23
2023: 264
24
2024: 160
25
2025: 74
26
2026: 30

Reports fell to 74 in 2025, down from an average of 212 in the two years before.

Related Entities for Dc-Defibrillator, Low-Energy, (Including Paddles)

Top Manufacturers

ZOLL MEDICAL CORP. 2,630
PHYSIO-CONTROL, INC. 2,554
ZOLL MEDICAL CORPORATION 1,954
PHYSIO-CONTROL, INC 1,224
PHILIPS MEDICAL SYSTEMS 855

Event Locations

6,441 (38.9%)
HOSPITAL 6,041 (36.4%)
OUTPATIENT TREATMENT FACILITY 2,444 (14.7%)
OTHER 606 (3.7%)
UNKNOWN 392 (2.4%)
I 213 (1.3%)
INVALID DATA 178 (1.1%)
HOME 111 (0.7%)
OUTPATIENT DIAGNOSTIC FACILITY 45 (0.3%)
AMBULATORY SURGICAL FACILITY 27 (0.2%)
NO INFORMATION 25 (0.2%)
NURSING HOME 21 (0.1%)
NOT APPLICABLE 12 (0.1%)
CLINIC - WALK IN, OTHER 6 (0.0%)
IN TRANSIT TO USER/MEDICAL FACILITY 6 (0.0%)
PUBLIC VENUE 6 (0.0%)
SCHOOL 3 (0.0%)
PUBLIC BUILDING 1 (0.0%)
RADIOLOGY DEPARTMENT 1 (0.0%)

Compare ZOLL MEDICAL CORP. vs PHYSIO-CONTROL, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Dc-Defibrillator, Low-Energy,: 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 (16,579 here).

Applier, Surgical, Clip 16,547 Prosthesis 16,505 Cardiac Ablation Percutaneous Catheter 16,442 Prosthesis 16,332

Similar death-typed counts

Nearest other device types by death-typed report count (943 here), distinct from the volume row.

Filter, Intravascular, Cardiovascular 929 Wire, Guide, Catheter 927 Catheter, Percutaneous 903 Heart-Valve, Mechanical 901

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

Disclaimer: MAUDE figures for Dc-Defibrillator, Low-Energy, 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 Dc-Defibrillator, Low-Energy,; 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.