Warmer, infant radiant: medical device reports filed with FDA

5,765 reports carry this product code, 1992–2026; 14 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,765
reports with this product code: 0% of all MAUDE reports; 375
reports, 12 months to August 2026: 392 in the 12 months before; 96.3%
classified as malfunction: 62.3% across all reports; 0.3%
classified as death, as reported: 0.9% across all reports

Product code FMT is FDA's classification for "Warmer, infant radiant" (general Hospital panel), a class 2 device. 5,765 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

375 reports arrived in the 12 months to August 2026, close to the 392 of the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (96.3%), injury (1.9%) and other (1%). 14 brand names with a page on this site carry this code; the brands table is ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Panda iRes Warmer	2,500	13	0%	99.9%
Giraffe Warmer	891	14	0%	99.3%
Fisher & Paykel Healthcare	373	3,374	0.3%	98.9%
Cosycot Infant Warmer	296	0	0.3%	98%
Giraffe IRS	135	54	0%	100%
Giraffe OmniBed Carestation	37	108	0.3%	96.5%
Giraffe OmniBed	19	37	4.7%	75%
Aestiva 7900	1	2	0%	99.6%
Aestiva Mri	1	4	0.2%	98.7%
Avance	1	1,353	0.1%	99.2%
Carestation 620	1	1,402	0%	99.9%
Carestation 650	1	1,686	0%	99.8%
Deroyal	1	14	0.7%	72.7%
Hill-Rom	1	0	18.7%	31.1%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Datex-Ohmeda	3,754	65.1%
Fisher & Paykel Healthcare	1,409	24.4%
Draeger Medical Systems	34	0.6%
Ge Healthcare	21	0.4%
Deroyal Industries	20	0.3%
Hill-Rom	13	0.2%
Draeger Medical	11	0.2%
Hill-Rom Ritter	2	0%
Disetronic Medical Systems	1	0%
Ge Medical Systems	1	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death0.3%17

Injury1.9%112

Malfunction96.3%5,552

Other1%58

Not given0.5%26

Who filed

Manufacturer report96.2%5,548

Voluntary report1.4%81

User facility report0%0

Distributor report0%0

Not given2.4%136

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Material integrity problema problem with the device material	3,344	58%
Breakthe device broke	494	8.6%
Crackthe device cracked	424	7.4%
Pressure problem	352	6.1%
Device alarm system	111	1.9%
Material discolored	73	1.3%
Insufficient flow or under infusion	69	1.2%
No flow	60	1%
No audible alarm	54	0.9%
Electrical /electronic property probleman electrical or electronic problem	48	0.8%
Device displays incorrect message	47	0.8%
Gas/air leak	39	0.7%
Nonstandard device	37	0.6%
Detachment of device or device componentpart of the device came off	36	0.6%
Device operates differently than expectedthe device behaved unexpectedly	36	0.6%
Smoking	36	0.6%
Device issuea problem with the device	34	0.6%
Device sensing problem	34	0.6%
Overheating of device	33	0.6%
Fracturea broken bone	31	0.5%

Questions about warmer, infant radiant reports

What is product code FMT?

FDA's classification code for "Warmer, infant radiant", class 2, reviewed by the general Hospital panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,765 reports through August 2026, 375 of them in the latest 12 months.

Which brands appear most often?

Panda iRes Warmer (2,500), Giraffe Warmer (891), Fisher & Paykel Healthcare (373), Cosycot Infant Warmer (296) and Giraffe IRS (135). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." Brands differ in how many are in use, how long they have been sold and how reports are collected.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.