PlainHospital
2026 data FDA MAUDE openFDA FDA Class I

Mattress, Flotation Therapy, Non-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 I (lowest regulatory risk tier, general controls), regulated under 21 CFR §880.5150 (General Hospital panel).

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FDA MAUDE casebook

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

#555 of 1000 · 1,569 reports · 1992–2026

  • BOOK 1,569 reports
  • RANK #555 of 1000
  • DEATH 35 death-typed
  • INJ 179 injury-typed
  • MALF 1,273 malfunction
  • SPAN 1992–2026
  • PEAK 2024: 433
  • PHOTO Wrench

Nearest event-volume peer: Wrench (2 report gap)

Mattress, Flotation Therapy, Non-Powered sits #555 of 1000 among tracked device types with 1,569 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

Mattress, Flotation Therapy, Non-Powered carries 11.4% INJURY-coded reports, 18.9pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 2.2% corpus 1.5% · above corpus mean (+0.7 pp)
  • INJ 11.4% corpus 30.3% · below corpus mean (-18.9 pp)
  • MALF 81.1% corpus 64.8% · above corpus mean (+16.3 pp)

Lead product-problem code Delamination is 13% of coded problems · Lead manufacturer STRYKER MEDICAL-KALAMAZOO accounts for 45% of manufacturer-tagged reports · Top event location is 78% of location-tagged rows .

Mattress, Flotation Therapy, Non-Powered in the event-volume neighbourhood

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

reports

What this shows Mattress, Flotation Therapy, Non-Powered carries 1,569 MAUDE reports, ranked #555 of 1000.

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

Event Types

Malfunction 1,273 (81.1%)
Injury 179 (11.4%)
Other 50 (3.2%)
Death 35 (2.2%)
31 (2.0%)
No answer provided 1 (0.1%)

Patient Outcomes

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

1,232 (78.0%)
Other 238 (15.1%)
Required Intervention 44 (2.8%)
Death 32 (2.0%)
Hospitalization 19 (1.2%)
R 6 (0.4%)
Disability 3 (0.2%)
D 1 (0.1%)
H 1 (0.1%)
O 1 (0.1%)
S 1 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Delamination 159
Device Slipped 155
Moisture Damage 117
Material Integrity Problem 116
Break 68
Insufficient Device Problem Information 68
Use of Device Problem 63
Device Contamination with Body Fluid 61
Device Emits Odor 57
Adverse Event Without Identified Device or Use Problem 55
Fracture 52
Maintenance Does Not Comply To Manufacturers Recommendations 47
Device Contamination With Biological Material 46
Device Operates Differently Than Expected 43
Material Deformation 36
Nonstandard Device 34
Moisture or Humidity Problem 27
Increase in Pressure 26
Unknown (for use when the device problem is not known) 24
Naturally Worn 13

Yearly Trend

92
1992: 1
95
1995: 1
99
1999: 3
00
2000: 1
01
2001: 3
02
2002: 1
03
2003: 3
04
2004: 10
05
2005: 10
06
2006: 5
07
2007: 4
08
2008: 15
09
2009: 23
10
2010: 36
11
2011: 119
12
2012: 47
13
2013: 164
14
2014: 207
15
2015: 74
16
2016: 62
17
2017: 27
18
2018: 131
19
2019: 45
20
2020: 16
21
2021: 13
22
2022: 44
23
2023: 23
24
2024: 433
25
2025: 39
26
2026: 9

Reports fell to 39 in 2025, down from an average of 228 in the two years before.

Related Entities for Mattress, Flotation Therapy, Non-Powered

Top Manufacturers

STRYKER MEDICAL-KALAMAZOO 339
STRYKER MEDICAL 320
HILL-ROM, INC. 87

Event Locations

1,223 (77.9%)
I 225 (14.3%)
HOSPITAL 84 (5.4%)
NURSING HOME 13 (0.8%)
NO INFORMATION 12 (0.8%)
HOME 9 (0.6%)
INVALID DATA 1 (0.1%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.1%)
UNKNOWN 1 (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, Flotation Therapy, Non-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 (1,569 here).

Wrench 1,571 Tube 1,573 Prosthesis 1,564 Device 1,561

Similar death-typed counts

Nearest other device types by death-typed report count (35 here), distinct from the volume row.

Adhesive 35 Balloon Aortic Valvuloplasty 35 Electrocardiograph 35 Fluid Jet Removal System 35

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Mattress, Flotation Therapy, Non-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 Mattress, Flotation Therapy, Non-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.