PlainHospital
2026 data FDA MAUDE openFDA FDA Class II

System, Hypothermia, Intravenous, Cooling

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 §870.5900 (Cardiovascular panel).

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book System, Hypothermia, Intravenous, Cooling LIGHT-BOOK · MAUDE

#343 of 1000 · 4,389 reports · 2005–2026

  • BOOK 4,389 reports
  • RANK #343 of 1000
  • DEATH 44 death-typed
  • INJ 261 injury-typed
  • MALF 4,075 malfunction
  • SPAN 2005–2026
  • PEAK 2022: 511
  • PHOTO Orthosis

Nearest event-volume peer: Orthosis, Spondylolisthesis Spinal Fixation (3 report gap)

System, Hypothermia, Intravenous, Cooling sits #343 of 1000 among tracked device types with 4,389 MAUDE reports spanning 2005–2026. 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

System, Hypothermia, Intravenous, Cooling carries 92.8% MALFUNCTION-coded reports, 28.0pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.0% corpus 1.5% · below corpus mean (-0.5 pp)
  • INJ 5.9% corpus 30.3% · below corpus mean (-24.3 pp)
  • MALF 92.8% corpus 64.8% · above corpus mean (+28.0 pp)

Lead product-problem code Visual Prompts will not Clear is 28% of coded problems · Lead manufacturer ZOLL CIRCULATION accounts for 100% of manufacturer-tagged reports · Top event location I is 55% of location-tagged rows .

System, Hypothermia, Intravenous, Cooling in the event-volume neighbourhood

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

reports

What this shows System, Hypothermia, Intravenous, Cooling carries 4,389 MAUDE reports, ranked #343 of 1000.

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

Event Types

Malfunction 4,075 (92.8%)
Injury 261 (5.9%)
Death 44 (1.0%)
7 (0.2%)
Other 2 (0.0%)

Patient Outcomes

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

4,002 (90.3%)
Other 205 (4.6%)
Death 58 (1.3%)
Required Intervention 57 (1.3%)
O 29 (0.7%)
R 28 (0.6%)
Life Threatening 20 (0.5%)
Hospitalization 18 (0.4%)
Congenital Anomaly 6 (0.1%)
L 4 (0.1%)
Disability 4 (0.1%)
D 2 (0.0%)
H 1 (0.0%)

Top Product Problems

Visual Prompts will not Clear 1,600
Fluid/Blood Leak 777
Material Integrity Problem 741
Device Operates Differently Than Expected 518
Use of Device Problem 483
Device Displays Incorrect Message 416
Leak/Splash 246
Adverse Event Without Identified Device or Use Problem 174
Device Issue 139
Insufficient Cooling 78
Temperature Problem 75
Failure to Power Up 67
Unexpected Shutdown 59
Device Operational Issue 52
Difficult to Remove 47
Insufficient Heating 45
No Display/Image 40
Difficult to Advance 31
Noise, Audible 26
Insufficient Device Problem Information 22

Yearly Trend

05
2005: 1
06
2006: 4
07
2007: 4
08
2008: 8
09
2009: 4
10
2010: 9
11
2011: 7
12
2012: 14
13
2013: 31
14
2014: 41
15
2015: 32
16
2016: 311
17
2017: 450
18
2018: 509
19
2019: 436
20
2020: 415
21
2021: 461
22
2022: 511
23
2023: 373
24
2024: 343
25
2025: 276
26
2026: 149

Reports in 2025 (276) held close to the prior two-year average of 358.

Related Entities for System, Hypothermia, Intravenous, Cooling

Top Manufacturers

ZOLL CIRCULATION 3,433

Event Locations

I 2,399 (54.7%)
1,881 (42.9%)
HOSPITAL 79 (1.8%)
NO INFORMATION 29 (0.7%)
OTHER 1 (0.0%)

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for System, Hypothermia, Intravenous, Cooling: 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 (4,389 here).

Orthosis, Spondylolisthesis Spinal Fixation 4,392 Intestinal Stimulator 4,382 Implant, Eye Valve 4,379 Pack, Hot Or Cold, Disposable 4,404

Similar death-typed counts

Nearest other device types by death-typed report count (44 here), distinct from the volume row.

Filler, Bone Void, Calcium Compound 44 Implant, Endosseous, Root-Form 44 Bath, Hydro-Massage 43 Filler 45

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

Disclaimer: MAUDE figures for System, Hypothermia, Intravenous, Cooling 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, Hypothermia, Intravenous, Cooling; 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.