2026 data FDA MAUDE openFDA FDA Class II

Bed, Air Fluidized

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 §890.5160 (Physical Medicine panel).

FDA MAUDE casebook

openFDA event book Bed, Air Fluidized LIGHT-BOOK · MAUDE

#578 of 1000 · 1,460 reports · 1992–2026

  • BOOK 1,460 reports
  • RANK #578 of 1000
  • DEATH 33 death-typed
  • INJ 161 injury-typed
  • MALF 1,164 malfunction
  • SPAN 1992–2026
  • PEAK 2013: 352
  • PHOTO Indicator

Nearest event-volume peer: Indicator, Biological Sterilization Process (9 report gap)

Bed, Air Fluidized sits #578 of 1000 among tracked device types with 1,460 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 →

Injury-coded reports sit below the device-type norm

Bed, Air Fluidized carries 11.0% INJURY-coded reports, 19.3pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.3% corpus 1.5% · above corpus mean (+0.8 pp)
  • INJ 11.0% corpus 30.3% · below corpus mean (-19.3 pp)
  • MALF 79.7% corpus 64.8% · above corpus mean (+14.9 pp)

Lead product-problem code Device Slipped is 46% of coded problems · Lead manufacturer HILL-ROM, INC. accounts for 50% of manufacturer-tagged reports · Top event location is 80% of location-tagged rows .

Bed, Air Fluidized in the event-volume neighbourhood

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

reports

What this shows Bed, Air Fluidized carries 1,460 MAUDE reports, ranked #578 of 1000.

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

Event Types

Malfunction 1,164 (79.7%)
Injury 161 (11.0%)
Other 67 (4.6%)
35 (2.4%)
Death 33 (2.3%)

Patient Outcomes

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

1,168 (78.9%)
Other 144 (9.7%)
Required Intervention 66 (4.5%)
Death 33 (2.2%)
Hospitalization 26 (1.8%)
R 16 (1.1%)
Life Threatening 15 (1.0%)
L 4 (0.3%)
O 3 (0.2%)
S 3 (0.2%)
Disability 3 (0.2%)

Top Product Problems

Device Slipped 577
Material Split, Cut or Torn 166
Unintended Movement 85
Activation Problem 59
Unknown (for use when the device problem is not known) 52
Mechanical Problem 40
Device Operates Differently Than Expected 36
Leak/Splash 27
Sparking 27
Smoking 24
Break 21
Device Inoperable 21
Device Emits Odor 19
Insufficient Device Problem Information 18
Adverse Event Without Identified Device or Use Problem 16
Deflation, cause unknown 16
Flare or Flash 16
Inflation Problem 16
Fire 15
Use of Device Problem 15

Yearly Trend

92
1992: 1
93
1993: 5
94
1994: 10
95
1995: 18
96
1996: 23
97
1997: 15
98
1998: 13
99
1999: 10
00
2000: 11
01
2001: 11
02
2002: 29
03
2003: 10
04
2004: 15
05
2005: 16
06
2006: 13
07
2007: 9
08
2008: 19
09
2009: 29
10
2010: 14
11
2011: 23
12
2012: 12
13
2013: 352
14
2014: 282
15
2015: 51
16
2016: 10
17
2017: 28
18
2018: 22
19
2019: 15
20
2020: 3
21
2021: 2
22
2022: 18
23
2023: 60
24
2024: 80
25
2025: 173
26
2026: 58

Reports rose to 173 in 2025, up from an average of 70 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Bed, Air Fluidized

Event Locations

1,167 (79.9%)
HOSPITAL 161 (11.0%)
I 60 (4.1%)
HOME 22 (1.5%)
NURSING HOME 17 (1.2%)
NO INFORMATION 14 (1.0%)
INVALID DATA 9 (0.6%)
OTHER 6 (0.4%)
OUTPATIENT TREATMENT FACILITY 3 (0.2%)
UNKNOWN 1 (0.1%)

Compare HILL-ROM, INC. vs BAXTER HEALTHCARE CORPORATION →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Bed, Air Fluidized: 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 (1,460 here).

Similar death-typed counts

Nearest other device types by death-typed report count (33 here), distinct from the volume row.

Disclaimer: MAUDE figures for Bed, Air Fluidized 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 Bed, Air Fluidized; 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.