2026 data FDA MAUDE openFDA FDA Class II

Bed, Flotation Therapy, Powered

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 §890.5170 (Physical Medicine panel).

FDA MAUDE casebook

openFDA event book Bed, Flotation Therapy, Powered LIGHT-BOOK · MAUDE

#627 of 1000 · 1,182 reports · 1994–2026

  • BOOK 1,182 reports
  • RANK #627 of 1000
  • DEATH 42 death-typed
  • INJ 198 injury-typed
  • MALF 897 malfunction
  • SPAN 1994–2026
  • PEAK 2024: 392
  • PHOTO Endovascular Suturing…

Nearest event-volume peer: Endovascular Suturing System (1 report gap)

Bed, Flotation Therapy, Powered sits #627 of 1000 among tracked device types with 1,182 MAUDE reports spanning 1994–2026. 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, Flotation Therapy, Powered carries 16.8% INJURY-coded reports, 13.5pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.6% corpus 1.5% · above corpus mean (+2.0 pp)
  • INJ 16.8% corpus 30.3% · below corpus mean (-13.5 pp)
  • MALF 75.9% corpus 64.8% · above corpus mean (+11.1 pp)

Lead product-problem code Material Split, Cut or Torn is 25% of coded problems · Lead manufacturer BAXTER HEALTHCARE CORPORATION accounts for 32% of manufacturer-tagged reports · Top event location is 80% of location-tagged rows .

Bed, Flotation Therapy, Powered in the event-volume neighbourhood

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

reports

What this shows Bed, Flotation Therapy, Powered carries 1,182 MAUDE reports, ranked #627 of 1000.

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

Event Types

Malfunction 897 (75.9%)
Injury 198 (16.8%)
Death 42 (3.6%)
Other 31 (2.6%)
14 (1.2%)

Patient Outcomes

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

818 (68.5%)
Other 261 (21.8%)
Death 42 (3.5%)
Required Intervention 36 (3.0%)
R 10 (0.8%)
Life Threatening 10 (0.8%)
Hospitalization 8 (0.7%)
H 3 (0.3%)
O 3 (0.3%)
Disability 3 (0.3%)
L 1 (0.1%)

Top Product Problems

Material Split, Cut or Torn 197
Unintended Movement 92
Insufficient Device Problem Information 52
Use of Device Problem 46
Positioning Failure 45
Activation Problem 42
Device Slipped 42
Unknown (for use when the device problem is not known) 36
Inflation Problem 35
Adverse Event Without Identified Device or Use Problem 30
Smoking 26
Pressure Problem 22
Mechanical Problem 19
Sparking 17
Appropriate Device Problem Term/Code Not Available 14
Device Operates Differently Than Expected 14
Deflation Problem 13
Device Inoperable 11
Fire 11
No Audible Alarm 10

Yearly Trend

94
1994: 2
96
1996: 1
97
1997: 12
98
1998: 7
99
1999: 5
00
2000: 6
02
2002: 7
03
2003: 21
04
2004: 10
05
2005: 5
06
2006: 10
07
2007: 7
08
2008: 10
09
2009: 35
10
2010: 28
11
2011: 15
12
2012: 9
13
2013: 15
14
2014: 35
15
2015: 28
16
2016: 42
17
2017: 22
18
2018: 20
19
2019: 4
20
2020: 9
21
2021: 56
22
2022: 22
23
2023: 111
24
2024: 392
25
2025: 143
26
2026: 93

Reports fell to 143 in 2025, down from an average of 252 in the two years before.

Related Entities for Bed, Flotation Therapy, Powered

Event Locations

945 (79.9%)
I 132 (11.2%)
HOSPITAL 76 (6.4%)
NURSING HOME 13 (1.1%)
INVALID DATA 6 (0.5%)
NO INFORMATION 4 (0.3%)
HOME 3 (0.3%)
OTHER 2 (0.2%)
UNKNOWN 1 (0.1%)

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

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Bed, Flotation Therapy, Powered: 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 (1,182 here).

Similar death-typed counts

Nearest other device types by death-typed report count (42 here), distinct from the volume row.

Disclaimer: MAUDE figures for Bed, Flotation Therapy, Powered 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, Flotation Therapy, Powered; 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.