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Bed, Patient Rotation, Powered

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FDA MAUDE adverse event data · 1992–2026

What the Data Shows About Bed, Patient Rotation, Powered

The FDA MAUDE database aggregates 811 adverse-event reports for Bed, Patient Rotation, Powered spanning the period from 1992 through 2026. Of these, 30 are classified as death reports, 216 as injury reports, and 523 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 12 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Adverse Event Without Identified Device or Use Problem topping the list at 77 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 31 years of MAUDE data, with the peak single-year volume reaching 294 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 8 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on . This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.

811
Total Reports
30
Death Reports
216
Injury Reports
523
Malfunctions

Event Types

Malfunction 523 (64.5%)
Injury 216 (26.6%)
30 (3.7%)
Death 30 (3.7%)
Other 12 (1.5%)

Patient Outcomes

377 (45.8%)
Other 331 (40.2%)
Required Intervention 46 (5.6%)
Death 32 (3.9%)
Hospitalization 14 (1.7%)
R 5 (0.6%)
S 5 (0.6%)
Life Threatening 5 (0.6%)
Disability 4 (0.5%)
Congenital Anomaly 2 (0.2%)
L 1 (0.1%)
O 1 (0.1%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 77
Difficult to Open or Close 17
Insufficient Information 16
Electrical /Electronic Property Problem 11
Use of Device Problem 9
Device Handling Problem 8
Positioning Problem 8
Break 6
Patient Device Interaction Problem 6
Device Operates Differently Than Expected 5
Human Factors Issue 4
Material Too Soft/Flexible 4
Mechanical Problem 4
No Apparent Adverse Event 4
Patient-Device Incompatibility 4
Unintended Movement 4
Cut In Material 3
Defective Component 3
Device Inoperable 3
Device Issue 3

Yearly Trend

92
1992: 3
93
1993: 1
94
1994: 2
95
1995: 2
96
1996: 2
97
1997: 1
00
2000: 1
02
2002: 3
03
2003: 6
05
2005: 2
06
2006: 6
07
2007: 7
08
2008: 4
09
2009: 11
10
2010: 26
11
2011: 48
12
2012: 69
13
2013: 294
14
2014: 80
15
2015: 40
16
2016: 26
17
2017: 35
18
2018: 28
19
2019: 27
20
2020: 29
21
2021: 11
22
2022: 6
23
2023: 20
24
2024: 7
25
2025: 12
26
2026: 2

Related Entities for Bed, Patient Rotation, Powered

Event Locations

608 (75.0%)
I 135 (16.6%)
HOSPITAL 50 (6.2%)
NO INFORMATION 7 (0.9%)
NURSING HOME 4 (0.5%)
HOME 3 (0.4%)
OTHER 3 (0.4%)
INVALID DATA 1 (0.1%)

Compare STRYKER MEDICAL-KALAMAZOO vs INVACARE FLORIDA OPERATIONS →

Data Source

FDA Manufacturer and User Facility Device Experience (MAUDE) database via the openFDA API. Reports are submitted by manufacturers, healthcare facilities, and patients. Report counts do not indicate a device is unsafe — higher-use devices naturally generate more reports.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from the FDA MAUDE database. Consult a qualified professional before making decisions based on this data.