2026 data FDA MAUDE openFDA FDA Class II

Compressor, Cardiac, External

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 §870.5200 (Cardiovascular panel).

FDA MAUDE casebook

openFDA event book Compressor, Cardiac, External MID-BOOK · MAUDE

#203 of 1000 · 11,220 reports · 1997–2026

  • BOOK 11,220 reports
  • RANK #203 of 1000
  • DEATH 206 death-typed
  • INJ 234 injury-typed
  • MALF 10,748 malfunction
  • SPAN 1997–2026
  • PEAK 2013: 1,268
  • PHOTO Recorder

Nearest event-volume peer: Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection) (6 report gap)

Compressor, Cardiac, External sits #203 of 1000 among tracked device types with 11,220 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

Compressor, Cardiac, External carries 95.8% MALFUNCTION-coded reports, 31.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.8% corpus 1.5% · near corpus mean (+0.3 pp)
  • INJ 2.1% corpus 30.3% · below corpus mean (-28.2 pp)
  • MALF 95.8% corpus 64.8% · above corpus mean (+31.0 pp)

Lead product-problem code Visual Prompts will not Clear is 36% of coded problems · Lead manufacturer ZOLL CIRCULATION accounts for 97% of manufacturer-tagged reports · Top event location is 58% of location-tagged rows .

Compressor, Cardiac, External in the event-volume neighbourhood

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

reports

What this shows Compressor, Cardiac, External carries 11,220 MAUDE reports, ranked #203 of 1000.

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

Event Types

Malfunction 10,748 (95.8%)
Injury 234 (2.1%)
Death 206 (1.8%)
Other 21 (0.2%)
11 (0.1%)

Patient Outcomes

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

9,476 (84.1%)
Other 1,378 (12.2%)
Death 242 (2.1%)
Required Intervention 48 (0.4%)
O 26 (0.2%)
Hospitalization 22 (0.2%)
Life Threatening 20 (0.2%)
R 16 (0.1%)
Disability 12 (0.1%)
L 10 (0.1%)
D 7 (0.1%)
Congenital Anomaly 7 (0.1%)
H 5 (0.0%)

Top Product Problems

Visual Prompts will not Clear 4,628
Device Displays Incorrect Message 2,470
Device Operates Differently Than Expected 1,044
Use of Device Problem 987
Device Operational Issue 832
Battery Problem 592
Failure to Power Up 392
Electrical /Electronic Property Problem 222
No Display/Image 222
Adverse Event Without Identified Device or Use Problem 207
Device Inoperable 198
Break 174
Display or Visual Feedback Problem 168
Device Stops Intermittently 155
Unexpected Shutdown 153
Low Battery 125
Premature Discharge of Battery 123
Loss of Power 116
Noise, Audible 104
Device Issue 91

Yearly Trend

97
1997: 9
98
1998: 3
99
1999: 5
00
2000: 2
01
2001: 10
02
2002: 7
03
2003: 74
04
2004: 56
05
2005: 34
06
2006: 5
07
2007: 8
08
2008: 13
09
2009: 9
10
2010: 7
11
2011: 16
12
2012: 483
13
2013: 1,268
14
2014: 664
15
2015: 674
16
2016: 639
17
2017: 679
18
2018: 783
19
2019: 706
20
2020: 844
21
2021: 755
22
2022: 730
23
2023: 765
24
2024: 710
25
2025: 698
26
2026: 564

Reports in 2025 (698) held close to the prior two-year average of 738.

Related Entities for Compressor, Cardiac, External

Event Locations

6,538 (58.3%)
I 4,482 (39.9%)
HOSPITAL 88 (0.8%)
OTHER 46 (0.4%)
NO INFORMATION 38 (0.3%)
AMBULATORY SURGICAL FACILITY 10 (0.1%)
OUTPATIENT TREATMENT FACILITY 9 (0.1%)
HOME 3 (0.0%)
INVALID DATA 3 (0.0%)
AMBULATORY HEALTH CARE FACILITY 2 (0.0%)
IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.0%)

Compare ZOLL CIRCULATION vs DEFIBTECH, L.L.C. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Compressor, Cardiac, External: 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 (11,220 here).

Similar death-typed counts

Nearest other device types by death-typed report count (206 here), distinct from the volume row.

Disclaimer: MAUDE figures for Compressor, Cardiac, External 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 Compressor, Cardiac, External; 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.