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 Class II (moderate risk, special controls required), regulated under 21 CFR §880.5130 (General Hospital panel).
FDA MAUDE casebook
openFDA event book Warmer, Infant Radiant LIGHT-BOOK · MAUDE
#298 of 1000 · 5,708 reports · 1992–2026
- BOOK 5,708 reports
- RANK #298 of 1000
- DEATH 17 death-typed
- INJ 110 injury-typed
- MALF 5,497 malfunction
- SPAN 1992–2026
- PEAK 2020: 1,605
- PHOTO Prosthesis
Nearest event-volume peer: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer (32 report gap)
Warmer, Infant Radiant sits #298 of 1000 among tracked device types with 5,708 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 →
Malfunction reports run above the device-type norm
Warmer, Infant Radiant carries 96.3% MALFUNCTION-coded reports, 31.5pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 0.3% corpus 1.5% · below corpus mean (-1.2 pp)
- INJ 1.9% corpus 30.3% · below corpus mean (-28.4 pp)
- MALF 96.3% corpus 64.8% · above corpus mean (+31.5 pp)
Lead product-problem code Material Integrity Problem is 62% of coded problems · Lead manufacturer DATEX-OHMEDA, INC. accounts for 77% of manufacturer-tagged reports · Top event location I is 64% of location-tagged rows .
Warmer, Infant Radiant in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Holder
Holder, Head, Neurosurgical (Skull Clamp)
5,826 reports
- Extended Dept…
Extended Depth Of Focus Intraocular Lens
5,816 reports
- Catheter
Catheter, Irrigation
5,798 reports
- Warmer (this)
Warmer, Infant Radiant
5,708 reports
- Prosthesis
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
5,676 reports
- Prosthesis
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
5,649 reports
What this shows Warmer, Infant Radiant carries 5,708 MAUDE reports, ranked #298 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 363 in 2025, up from an average of 216 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Warmer, Infant Radiant
Top Manufacturers
Event Locations
Compare DATEX-OHMEDA, INC. vs FISHER & PAYKEL HEALTHCARE LTD →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Warmer, Infant Radiant: 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 (5,708 here).
Similar death-typed counts
Nearest other device types by death-typed report count (17 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
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.