2026 data FDA MAUDE openFDA FDA Class II

Mattress, Air Flotation, Alternating Pressure

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 §880.5550 (General Hospital panel).

FDA MAUDE casebook

openFDA event book Mattress LIGHT-BOOK · MAUDE

#447 of 1000 · 2,524 reports · 1993–2026

  • BOOK 2,524 reports
  • RANK #447 of 1000
  • DEATH 154 death-typed
  • INJ 767 injury-typed
  • MALF 1,316 malfunction
  • SPAN 1993–2026
  • PEAK 2012: 303
  • PHOTO Gauze/Sponge

Nearest event-volume peer: Gauze/Sponge, Internal, X-Ray Detectable (3 report gap)

Mattress, Air Flotation, Alternating Pressure sits #447 of 1000 among tracked device types with 2,524 MAUDE reports spanning 1993–2026. 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 sit below the device-type norm

Mattress carries 52.1% MALFUNCTION-coded reports, 12.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 6.1% corpus 1.5% · above corpus mean (+4.6 pp)
  • INJ 30.4% corpus 30.3% · near corpus mean (+0.1 pp)
  • MALF 52.1% corpus 64.8% · below corpus mean (-12.7 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 18% of coded problems · Lead manufacturer STRYKER MEDICAL-KALAMAZOO accounts for 44% of manufacturer-tagged reports · Top event location is 69% of location-tagged rows .

Mattress in the event-volume neighbourhood

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

reports

What this shows Mattress, Air Flotation, Alternating Pressure carries 2,524 MAUDE reports, ranked #447 of 1000.

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

Event Types

Malfunction 1,316 (52.1%)
Injury 767 (30.4%)
166 (6.6%)
Death 154 (6.1%)
Other 121 (4.8%)

Patient Outcomes

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

1,251 (47.8%)
Other 769 (29.4%)
Hospitalization 169 (6.5%)
Required Intervention 154 (5.9%)
Death 147 (5.6%)
R 48 (1.8%)
H 29 (1.1%)
O 15 (0.6%)
Life Threatening 13 (0.5%)
L 8 (0.3%)
S 7 (0.3%)
Disability 4 (0.2%)
Invalid Data 2 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 325
Insufficient Device Problem Information 285
Moisture Damage 243
Inflation Problem 123
Deflation Problem 105
Increase in Pressure 81
Use of Device Problem 73
Unknown (for use when the device problem is not known) 63
Sparking 62
Device Operates Differently Than Expected 58
Moisture or Humidity Problem 49
Decrease in Pressure 48
Break 47
Failure to Power Up 47
Gas/Air Leak 33
Fire 32
Smoking 31
Air Leak 29
Electronic Property Issue 28
Improper or Incorrect Procedure or Method 27

Yearly Trend

93
1993: 2
95
1995: 4
96
1996: 7
97
1997: 36
98
1998: 17
99
1999: 15
00
2000: 11
01
2001: 18
02
2002: 16
03
2003: 12
04
2004: 16
05
2005: 8
06
2006: 28
07
2007: 33
08
2008: 35
09
2009: 33
10
2010: 56
11
2011: 291
12
2012: 303
13
2013: 223
14
2014: 80
15
2015: 80
16
2016: 50
17
2017: 56
18
2018: 115
19
2019: 101
20
2020: 58
21
2021: 47
22
2022: 75
23
2023: 197
24
2024: 254
25
2025: 129
26
2026: 118

Reports fell to 129 in 2025, down from an average of 226 in the two years before.

Related Entities for Mattress, Air Flotation, Alternating Pressure

Event Locations

1,746 (69.2%)
I 292 (11.6%)
HOSPITAL 266 (10.5%)
NURSING HOME 99 (3.9%)
HOME 74 (2.9%)
OTHER 19 (0.8%)
INVALID DATA 9 (0.4%)
NO INFORMATION 6 (0.2%)
UNKNOWN 6 (0.2%)
NOT APPLICABLE 5 (0.2%)
OUTPATIENT TREATMENT FACILITY 2 (0.1%)

Compare STRYKER MEDICAL-KALAMAZOO vs STRYKER MEDICAL →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Mattress: 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 (2,524 here).

Similar death-typed counts

Nearest other device types by death-typed report count (154 here), distinct from the volume row.

Disclaimer: MAUDE figures for Mattress 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 Mattress; 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.