Mattress, air flotation, alternating pressure: medical device reports filed with FDA

2,643 reports carry this product code, 1993–2026; 5 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.

2,643
reports with this product code: 0% of all MAUDE reports; 278
reports, 12 months to August 2026: 237 in the 12 months before; 54.1%
classified as malfunction: 62.3% across all reports; 5.8%
classified as death, as reported: 0.9% across all reports

Product code FNM is FDA's classification for "Mattress, air flotation, alternating pressure" (general Hospital panel), a class 2 device. 2,643 medical device reports carry this product code, 0% of the MAUDE database, from September 1993 to August 2026.

278 reports arrived in the 12 months to August 2026, up 17% from 237 in 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 (54.1%), injury (29.2%) and death (5.8%). 5 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	Classified as death	Classified as malfunction
Pped Ctr Plus Delux 35x84	164	0%	100%
Xprt Sleep Surface	54	0%	74.7%
Hill-Rom	2	18.7%	31.1%
In Touch Zu	2	0.1%	96.1%
Drive Medical	1	10%	5.2%

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
Arjohuntleigh Polska Sp Z O O	115	4.4%
Stryker Medical	61	2.3%
Hill-Rom	30	1.1%
Invacare	28	1.1%
Kci USA	14	0.5%
Kinetic Concepts	10	0.4%
Invacare Florida Operations	7	0.3%
Stryker Medical Div	7	0.3%
Stryker Medical-Kalamazoo	7	0.3%
Hill-Rom Ritter	3	0.1%
Hill-Rom Batesville	2	0.1%
Medline Industries	1	0%
Stryker	1	0%
Stryker Instruments	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

Death5.8%154

Injury29.2%771

Malfunction54.1%1,430

Other4.6%122

Not given6.3%166

Who filed

Manufacturer report75.4%1,993

Voluntary report13.2%350

User facility report0%0

Distributor report5.8%153

Not given5.6%147

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	282	10.7%
Moisture damage	241	9.1%
Inflation problem	154	5.8%
Deflation problem	115	4.4%
Increase in pressure	81	3.1%
Gas/air leak	62	2.3%
Sparking	57	2.2%
Device operates differently than expectedthe device behaved unexpectedly	55	2.1%
Decrease in pressure	50	1.9%
Moisture or humidity problem	49	1.9%
Unintended deflation	48	1.8%
Breakthe device broke	46	1.7%
Failure to power up	43	1.6%
Electronic property issue	28	1.1%
Fire	28	1.1%
Air leak	27	1%
Other (for use when an appropriate device code cannot be identified)	27	1%
Entrapment of device	25	0.9%
Melted	25	0.9%
Improper or incorrect procedure or method	24	0.9%

Questions about mattress, air flotation, alternating pressure reports

What is product code FNM?

FDA's classification code for "Mattress, air flotation, alternating pressure", 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?

2,643 reports through August 2026, 278 of them in the latest 12 months.

Which brands appear most often?

Pped Ctr Plus Delux 35x84 (164), Xprt Sleep Surface (54), Hill-Rom (2), In Touch Zu (2) and Drive Medical (1). 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.