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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

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

#340 of 1000 · 4,279 reports · 2005–2026

  • BOOK 4,279 reports
  • RANK #340 of 1000
  • DEATH 44 death-typed
  • INJ 252 injury-typed
  • MALF 3,974 malfunction
  • SPAN 2005–2026
  • PEAK 2022: 511
  • PHOTO Implant, Eye Valve

Nearest event-volume peer: Implant, Eye Valve (11 report gap)

System, Hypothermia, Intravenous, Cooling sits #340 of 1000 among tracked device types with 4,279 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 →

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 1.0% corpus 1.5% · near corpus mean (-0.5 pp)
  • INJ 5.9% corpus 30.4% · below corpus mean (-24.5 pp)
  • MALF 92.9% corpus 64.5% · above corpus mean (+28.4 pp)

Lead product-problem code Visual Prompts will not Clear is 29% of coded problems · Lead manufacturer ZOLL CIRCULATION accounts for 100% of manufacturer-tagged reports · Top event location I is 56% 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 4,279 MAUDE reports, ranked #340 of 1000.

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

Event Types

Malfunction 3,974 (92.9%)
Injury 252 (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.

3,898 (90.2%)
Other 197 (4.6%)
Death 57 (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 1,550
Fluid/Blood Leak 747
Material Integrity Problem 722
Device Operates Differently Than Expected 492
Use of Device Problem 466
Device Displays Incorrect Message 401
Leak/Splash 237
Adverse Event Without Identified Device or Use Problem 147
Device Issue 139
Insufficient Cooling 70
Failure to Power Up 63
Temperature Problem 62
Unexpected Shutdown 55
Device Operational Issue 52
Insufficient Heating 42
Difficult to Remove 39
No Display/Image 38
Difficult to Advance 29
Noise, Audible 23
Power Problem 21

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: 39

Related Entities for System, Hypothermia, Intravenous, Cooling

Top Manufacturers

ZOLL CIRCULATION 3,433
ZOLL MEDICAL CORPORATION 6

Event Locations

I 2,399 (56.1%)
1,771 (41.4%)
HOSPITAL 79 (1.8%)
NO INFORMATION 29 (0.7%)
OTHER 1 (0.0%)

Compare ZOLL CIRCULATION vs ZOLL MEDICAL CORPORATION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for System, Hypothermia, Intravenous, Cooling, 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 (4,279 here).

Implant, Eye Valve 4,290 Intestinal Stimulator 4,295 Pack, Hot Or Cold, Disposable 4,263 Stimulator, Peripheral Nerve, Implanted 4,295

Similar death-typed counts

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

Catheter, Peritoneal, Long-Term Indwelling 44 Filler, Bone Void, Calcium Compound 44 Monitor, Physiological, Patient 44 System, Ablation, Microwave And Accessories 44

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.