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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#154 of 1000 · 16,560 reports · 1993–2026

  • BOOK 16,560 reports
  • RANK #154 of 1000
  • DEATH 942 death-typed
  • INJ 444 injury-typed
  • MALF 14,773 malfunction
  • SPAN 1993–2026
  • PEAK 1999: 1,291
  • PHOTO Unit

Nearest event-volume peer: Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (31 report gap)

Dc-Defibrillator, Low-Energy, (Including Paddles) sits #154 of 1000 among tracked device types with 16,560 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 →

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 5.7% corpus 1.5% · above corpus mean (+4.2 pp)
  • INJ 2.7% corpus 30.4% · below corpus mean (-27.8 pp)
  • MALF 89.2% corpus 64.5% · above corpus mean (+24.7 pp)

Lead product-problem code No Pacing is 28% 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 16,560 MAUDE reports, ranked #154 of 1000.

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

Event Types

Malfunction 14,773 (89.2%)
Death 942 (5.7%)
Injury 444 (2.7%)
Other 305 (1.8%)
96 (0.6%)

Patient Outcomes

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

10,643 (63.5%)
Other 4,577 (27.3%)
Death 950 (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

No Pacing 212
Failure to Deliver Shock/Stimulation 102
Unable to Obtain Readings 62
Pacing Problem 59
Failure of Device to Self-Test 46
Failure to Discharge 37
Break 34
Appropriate Term/Code Not Available 27
Insufficient Information 22
Failure to Charge 21
Device Operates Differently Than Expected 20
Loose or Intermittent Connection 20
Device Sensing Problem 15
Failure to Power Up 15
Battery Problem 13
Defibrillation/Stimulation Problem 13
Electrical /Electronic Property Problem 12
Output Problem 12
Crack 10
Failure to Deliver Energy 10

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: 1,214
09
2009: 1,056
10
2010: 635
11
2011: 388
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: 10

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

Top Manufacturers

ZOLL MEDICAL CORP. 2,630
PHYSIO-CONTROL, INC. 2,553
ZOLL MEDICAL CORPORATION 1,953
PHYSIO-CONTROL, INC 1,224
PHILIPS MEDICAL SYSTEMS 855

Event Locations

6,423 (38.8%)
HOSPITAL 6,041 (36.5%)
OUTPATIENT TREATMENT FACILITY 2,444 (14.8%)
OTHER 605 (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 similar MAUDE profiles

Two openFDA-derived peer sets for Dc-Defibrillator, Low-Energy,, 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 (16,560 here).

Unit, Electrosurgical, Endoscopic 16,529 Drills, Burrs, Trephines & Accessories 16,522 Aligner, Sequential 16,486 Catheter, Urological 16,473

Similar death-typed counts

Nearest other device types by death-typed report count (942 here), distinct from the volume row.

Filter, Intravascular, Cardiovascular 928 Wire, Guide, Catheter 895 Catheter, Thrombus Retriever 885 Heart-Valve, Mechanical 883

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.