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TPLC
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Device
bariatric bed
Definition
A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
Product Code
OSI
Regulation Number
880.5100
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
101
101
2015
124
124
2016
72
72
2017
7
7
2018
16
16
2019
22
22
2020
15
15
2021
30
39
2022
37
51
2023
176
185
2024
37
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
126
126
Break
77
77
Bent
46
46
Device Slipped
45
45
Sparking
36
36
Device Operates Differently Than Expected
26
26
Mechanical Problem
26
26
Smoking
24
24
Activation Problem
20
20
Unintended Movement
20
20
Material Frayed
19
19
Unintended System Motion
17
17
Adverse Event Without Identified Device or Use Problem
16
16
Fire
14
14
Incorrect Measurement
12
44
Electrical /Electronic Property Problem
12
12
Appropriate Term/Code Not Available
10
10
Positioning Failure
9
16
Use of Device Problem
9
9
Material Deformation
8
8
Material Protrusion/Extrusion
7
7
Detachment Of Device Component
7
7
No Audible Alarm
7
7
Device Alarm System
7
7
Loose or Intermittent Connection
7
7
Inflation Problem
7
7
Component Falling
6
6
Insufficient Information
6
6
Noise, Audible
6
6
Thermal Decomposition of Device
5
5
Self-Activation or Keying
5
5
Sticking
5
5
Component Missing
4
4
Connection Problem
4
4
Crack
4
4
Unintended Head Motion
4
4
Device Fell
4
4
No Apparent Adverse Event
4
4
Material Integrity Problem
3
3
Mechanics Altered
3
3
Melted
3
3
Collapse
3
3
Defective Alarm
3
3
Defective Component
3
3
Detachment of Device or Device Component
3
3
Electrical Shorting
3
3
Device Emits Odor
3
3
Device Inoperable
3
3
Improper or Incorrect Procedure or Method
2
2
Out-Of-Box Failure
2
2
Material Separation
2
2
Human Factors Issue
2
2
Human-Device Interface Problem
2
2
Split
2
2
Arcing
2
2
Malposition of Device
2
2
Disconnection
2
2
Peeled/Delaminated
2
2
Loss of Power
2
2
Material Fragmentation
2
2
Naturally Worn
2
2
Device Dislodged or Dislocated
2
2
Mechanical Jam
2
2
Torn Material
2
2
Pressure Problem
2
2
Unintended Electrical Shock
2
2
Sharp Edges
1
1
Patient Device Interaction Problem
1
1
Device Handling Problem
1
1
Activation Failure
1
1
Protective Measures Problem
1
1
Temperature Problem
1
1
Positioning Problem
1
1
Material Twisted/Bent
1
1
Leak/Splash
1
1
Failure to Pump
1
1
Product Quality Problem
1
1
Device Remains Activated
1
1
Misassembled
1
1
Nonstandard Device
1
1
Entrapment of Device
1
1
Material Discolored
1
1
Low Audible Alarm
1
1
Burst Container or Vessel
1
1
Circuit Failure
1
1
Patient-Device Incompatibility
1
1
Calibration Problem
1
1
Contamination /Decontamination Problem
1
1
Activation, Positioning or Separation Problem
1
1
Flare or Flash
1
1
Gas/Air Leak
1
1
Device-Device Incompatibility
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Overheating of Device
1
1
Device Stops Intermittently
1
1
Inadequate or Insufficient Training
1
1
Malfunction
1
1
Structural Problem
1
1
Failure to Align
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
222
261
No Known Impact Or Consequence To Patient
205
205
No Information
49
49
Insufficient Information
24
24
No Patient Involvement
23
23
Fall
23
23
No Consequences Or Impact To Patient
22
22
Pressure Sores
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Electric Shock
6
6
Laceration(s)
5
5
Bruise/Contusion
5
5
Unspecified Tissue Injury
5
5
Death
4
4
Pain
4
4
Discomfort
4
4
Injury
4
4
Skin Tears
3
3
Hip Fracture
2
2
Shock
2
2
Physical Entrapment
2
2
Bone Fracture(s)
2
2
Burn(s)
2
2
Cardiac Arrest
1
1
Corneal Edema
1
1
Dyspnea
1
1
Ecchymosis
1
1
Abrasion
1
1
Airway Obstruction
1
1
Erosion
1
1
Hematoma
1
1
Tissue Damage
1
1
Fracture, Arm
1
1
Needle Stick/Puncture
1
1
Low Oxygen Saturation
1
1
Complaint, Ill-Defined
1
1
Weight Changes
1
1
No Code Available
1
1
Localized Skin Lesion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Kreg Medical Inc.
II
Jun-05-2013
2
SCM True Air Technologies LLC
II
May-19-2014
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