2026 data FDA MAUDE openFDA

Warmer, Infant Radiant

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 MAUDE casebook

openFDA event book Warmer, Infant Radiant LIGHT-BOOK · MAUDE

#295 of 1000 · 5,554 reports · 1992–2026

  • BOOK 5,554 reports
  • RANK #295 of 1000
  • DEATH 17 death-typed
  • INJ 108 injury-typed
  • MALF 5,345 malfunction
  • SPAN 1992–2026
  • PEAK 2020: 1,605
  • PHOTO Pump, Breast, Powered

Nearest event-volume peer: Pump, Breast, Powered (14 report gap)

Warmer, Infant Radiant sits #295 of 1000 among tracked device types with 5,554 MAUDE reports spanning 1992–2026. 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 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
  • INJ 1.9% corpus 30.4% · below corpus mean (-28.5 pp)
  • MALF 96.2% corpus 64.5% · above corpus mean (+31.7 pp)

Lead product-problem code Material Integrity Problem is 72% of coded problems · Lead manufacturer DATEX-OHMEDA, INC. accounts for 78% of manufacturer-tagged reports · Top event location I is 66% of location-tagged rows .

Warmer, Infant Radiant in the event-volume neighbourhood

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

reports

What this shows Warmer, Infant Radiant carries 5,554 MAUDE reports, ranked #295 of 1000.

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

Event Types

Malfunction 5,345 (96.2%)
Injury 108 (1.9%)
Other 58 (1.0%)
26 (0.5%)
Death 17 (0.3%)

Patient Outcomes

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

5,277 (95.0%)
Other 143 (2.6%)
Required Intervention 80 (1.4%)
Death 16 (0.3%)
Hospitalization 14 (0.3%)
Life Threatening 11 (0.2%)
R 6 (0.1%)
L 4 (0.1%)
O 3 (0.1%)
Disability 3 (0.1%)

Top Product Problems

Material Integrity Problem 3,346
Break 340
Pressure Problem 278
Crack 193
Insufficient Flow or Under Infusion 66
Device Alarm System 48
Electrical /Electronic Property Problem 48
No Audible Alarm 48
No Flow 42
Nonstandard Device 34
Gas/Air Leak 31
Output Problem 30
Detachment of Device or Device Component 27
Device Issue 26
Incorrect, Inadequate or Imprecise Result or Readings 25
Mechanical Problem 23
Material Discolored 20
Fracture 18
Device Sensing Problem 17
Device Displays Incorrect Message 14

Yearly Trend

92
1992: 4
93
1993: 8
94
1994: 8
95
1995: 5
96
1996: 6
97
1997: 25
98
1998: 10
99
1999: 11
00
2000: 19
01
2001: 37
02
2002: 20
03
2003: 21
04
2004: 16
05
2005: 11
06
2006: 18
07
2007: 21
08
2008: 114
09
2009: 79
10
2010: 105
11
2011: 79
12
2012: 54
13
2013: 55
14
2014: 79
15
2015: 56
16
2016: 56
17
2017: 46
18
2018: 79
19
2019: 1,437
20
2020: 1,605
21
2021: 473
22
2022: 153
23
2023: 175
24
2024: 257
25
2025: 363
26
2026: 49

Related Entities for Warmer, Infant Radiant

Event Locations

I 3,638 (65.5%)
1,685 (30.3%)
HOSPITAL 183 (3.3%)
NOT APPLICABLE 26 (0.5%)
INVALID DATA 9 (0.2%)
NO INFORMATION 8 (0.1%)
HOME 2 (0.0%)
MATERNITY WARD - NURSERY 1 (0.0%)
OTHER 1 (0.0%)
UNKNOWN 1 (0.0%)

Compare DATEX-OHMEDA, INC. vs FISHER & PAYKEL HEALTHCARE LTD →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Warmer, Infant Radiant, 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 (5,554 here).

Similar death-typed counts

Nearest other device types by death-typed report count (17 here), distinct from the volume row.

Disclaimer: MAUDE figures for Warmer, Infant Radiant 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, Infant Radiant; 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.