What are FDA adverse event reports for Compressor, Cardiac, External?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Compressor, Cardiac, External, there are 10,811 total reports including 201 death reports and 225 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Compressor, Cardiac, External?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Compressor, Cardiac, External

Name: Compressor, Cardiac, External - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

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

#203 of 1000 · 10,811 reports · 1997–2026

BOOK 10,811 reports
RANK #203 of 1000
DEATH 201 death-typed
INJ 225 injury-typed
MALF 10,353 malfunction
SPAN 1997–2026
PEAK 2013: 1,268
PHOTO System

Nearest event-volume peer: System, Hemodynamic, Implantable (19 report gap)

Compressor, Cardiac, External sits #203 of 1000 among tracked device types with 10,811 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 →

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 1.9% corpus 1.5% · near corpus mean (+0.3 pp)
INJ 2.1% corpus 30.4% · below corpus mean (-28.4 pp)
MALF 95.8% corpus 64.5% · above corpus mean (+31.3 pp)

Lead product-problem code Visual Prompts will not Clear is 46% of coded problems · Lead manufacturer ZOLL CIRCULATION accounts for 97% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Catheter

11,029
Catheter

10,969
Image-Intensi…

10,959
Compressor (this)

10,811
System

10,792
Recorder

10,606

What this shows Compressor, Cardiac, External carries 10,811 MAUDE reports, ranked #203 of 1000.

Event Types

Malfunction 10,353 (95.8%)

Injury 225 (2.1%)

Death 201 (1.9%)

Other 21 (0.2%)

11 (0.1%)

Patient Outcomes

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

9,080 (83.6%)

Other 1,376 (12.7%)

Death 239 (2.2%)

Required Intervention 43 (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%)

Yearly Trend

1997: 9

1998: 3

1999: 5

2000: 2

2001: 10

2002: 7

2003: 74

2004: 56

2005: 34

2006: 5

2007: 8

2008: 13

2009: 9

2010: 7

2011: 16

2012: 483

2013: 1,268

2014: 664

2015: 674

2016: 639

2017: 679

2018: 783

2019: 706

2020: 844

2021: 755

2022: 730

2023: 765

2024: 710

2025: 698

2026: 155

Top Manufacturers

ZOLL CIRCULATION 6,334

DEFIBTECH, L.L.C. 126

PHYSIO-CONTROL, INC. - 3015876 38

Event Locations

6,131 (56.7%)

I 4,482 (41.5%)

HOSPITAL 87 (0.8%)

OTHER 46 (0.4%)

NO INFORMATION 38 (0.4%)

AMBULATORY SURGICAL FACILITY 10 (0.1%)

OUTPATIENT TREATMENT FACILITY 9 (0.1%)

INVALID DATA 3 (0.0%)

AMBULATORY HEALTH CARE FACILITY 2 (0.0%)

HOME 2 (0.0%)

IN TRANSIT TO USER/MEDICAL FACILITY 1 (0.0%)

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

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Compressor, Cardiac, External, 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 (10,811 here).

System, Hemodynamic, Implantable 10,792 Image-Intensified Fluoroscopic X-Ray System 10,959 Catheter 10,969 Recorder, Event, Implantable Cardiac, 10,606

Similar death-typed counts

Nearest other device types by death-typed report count (201 here), distinct from the volume row.

Controller 204 Heparin, Vascular Access Flush 206 Stent, Iliac 206 Stimulator, Spinal-Cord, Implanted 196

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

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.

Compressor, Cardiac, External

Event-type mix vs corpus