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2026 data FDA MAUDE openFDA FDA Class II

Warmer, Blood, Non-Electromagnetic Radiation

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 §864.9205 (Hematology panel).

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FDA MAUDE casebook

openFDA event book Warmer, Blood, Non-Electromagnetic Radiation LIGHT-BOOK · MAUDE

#472 of 1000 · 2,219 reports · 1998–2026

  • BOOK 2,219 reports
  • RANK #472 of 1000
  • DEATH 23 death-typed
  • INJ 26 injury-typed
  • MALF 2,150 malfunction
  • SPAN 1998–2026
  • PEAK 2022: 447
  • PHOTO Forceps

Nearest event-volume peer: Forceps (2 report gap)

Warmer, Blood, Non-Electromagnetic Radiation sits #472 of 1000 among tracked device types with 2,219 MAUDE reports spanning 1998–2026. 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

Warmer, Blood, Non-Electromagnetic Radiation carries 96.9% MALFUNCTION-coded reports, 32.1pp 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% · near corpus mean (-0.5 pp)
  • INJ 1.2% corpus 30.3% · below corpus mean (-29.1 pp)
  • MALF 96.9% corpus 64.8% · above corpus mean (+32.1 pp)

Lead product-problem code Fluid/Blood Leak is 29% of coded problems · Lead manufacturer SMITHS MEDICAL ASD, INC. accounts for 45% of manufacturer-tagged reports · Top event location is 66% of location-tagged rows .

Warmer, Blood, Non-Electromagnetic Radiation in the event-volume neighbourhood

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

reports

What this shows Warmer, Blood, Non-Electromagnetic Radiation carries 2,219 MAUDE reports, ranked #472 of 1000.

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

Event Types

Malfunction 2,150 (96.9%)
Injury 26 (1.2%)
Death 23 (1.0%)
Other 18 (0.8%)
2 (0.1%)

Patient Outcomes

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

2,030 (91.1%)
Other 133 (6.0%)
Death 24 (1.1%)
Required Intervention 16 (0.7%)
R 6 (0.3%)
Life Threatening 6 (0.3%)
O 4 (0.2%)
Hospitalization 3 (0.1%)
H 2 (0.1%)
L 2 (0.1%)
S 2 (0.1%)
Disability 1 (0.0%)

Top Product Problems

Fluid/Blood Leak 544
Device Alarm System 238
Temperature Problem 136
Pressure Problem 117
Leak/Splash 91
Insufficient Heating 82
Insufficient Flow or Under Infusion 81
Insufficient Device Problem Information 76
Overheating of Device 67
Appropriate Device Problem Term/Code Not Available 46
Break 45
Defective Component 40
False Alarm 39
Defective Alarm 37
Failure to Power Up 37
Excessive Heating 36
Device Markings/Labelling Problem 35
Failure to Pump 35
Infusion or Flow Problem 34
Crack 33

Yearly Trend

98
1998: 4
99
1999: 4
00
2000: 3
01
2001: 7
02
2002: 4
07
2007: 4
08
2008: 5
10
2010: 6
11
2011: 35
12
2012: 4
13
2013: 5
14
2014: 10
15
2015: 11
16
2016: 66
17
2017: 29
18
2018: 36
19
2019: 147
20
2020: 216
21
2021: 340
22
2022: 447
23
2023: 290
24
2024: 282
25
2025: 198
26
2026: 66

Reports in 2025 (198) held close to the prior two-year average of 286.

Related Entities for Warmer, Blood, Non-Electromagnetic Radiation

Top Manufacturers

SMITHS MEDICAL ASD, INC. 442
ST PAUL 350
SMITHS MEDICAL ASD, INC. 85
SMITHS MEDICAL ASD, INC 59
ICU MEDICAL, INC. 56

Event Locations

1,471 (66.3%)
I 654 (29.5%)
HOSPITAL 67 (3.0%)
NO INFORMATION 18 (0.8%)
OTHER 8 (0.4%)
NOT APPLICABLE 1 (0.0%)

Compare SMITHS MEDICAL ASD, INC. vs ST PAUL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Warmer, Blood, Non-Electromagnetic Radiation: 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 (2,219 here).

Forceps 2,217 Stimulator 2,224 Endoscopic Grasping/Cutting Instrument 2,211 Tray, Surgical, Instrument 2,231

Similar death-typed counts

Nearest other device types by death-typed report count (23 here), distinct from the volume row.

Cannula, Catheter 23 Electrode, Electrocardiograph 23 Gastrointestinal Tubes With Enteral Specifi… 23 Regulator, Pressure, Gas Cylinder 23

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

Disclaimer: MAUDE figures for Warmer, Blood, Non-Electromagnetic Radiation 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 Warmer, Blood, Non-Electromagnetic Radiation; 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.