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TPLC
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Device
mattress, air flotation, alternating pressure
Product Code
FNM
Regulation Number
880.5550
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
101
101
2020
58
58
2021
47
47
2022
75
75
2023
197
197
2024
37
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
151
151
Insufficient Information
73
73
Deflation Problem
55
55
Dent in Material
21
21
Sparking
19
19
Use of Device Problem
18
18
Increase in Pressure
18
18
Appropriate Term/Code Not Available
17
17
Inflation Problem
16
16
Unintended Deflation
13
13
No Apparent Adverse Event
12
12
Patient-Device Incompatibility
11
11
Electrical /Electronic Property Problem
10
10
Electrical Shorting
10
10
Detachment of Device or Device Component
7
7
Infusion or Flow Problem
7
7
Unintended Electrical Shock
7
7
Fire
7
7
Pressure Problem
6
6
Decrease in Pressure
5
5
Device Slipped
5
5
Mechanical Problem
4
4
Patient Device Interaction Problem
4
4
Protective Measures Problem
3
3
Installation-Related Problem
3
3
No Pressure
3
3
Device-Device Incompatibility
3
3
Difficult or Delayed Positioning
3
3
Smoking
3
3
Product Quality Problem
3
3
Contamination /Decontamination Problem
2
2
Defective Component
2
2
Disconnection
2
2
Use of Incorrect Control/Treatment Settings
2
2
Thermal Decomposition of Device
2
2
Malposition of Device
2
2
Gas/Air Leak
2
2
Therapeutic or Diagnostic Output Failure
2
2
Sharp Edges
2
2
Complete Loss of Power
2
2
Inaccurate Information
1
1
Unclear Information
1
1
Device Fell
1
1
Component Misassembled
1
1
Material Split, Cut or Torn
1
1
Noise, Audible
1
1
Improper Flow or Infusion
1
1
Pumping Problem
1
1
Device Damaged by Another Device
1
1
Device Dislodged or Dislocated
1
1
Flare or Flash
1
1
Positioning Problem
1
1
Power Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Protrusion/Extrusion
1
1
Material Twisted/Bent
1
1
Circuit Failure
1
1
Device Alarm System
1
1
Inability to Auto-Fill
1
1
Crack
1
1
Unintended System Motion
1
1
Energy Output Problem
1
1
Overheating of Device
1
1
Failure to Power Up
1
1
Loose or Intermittent Connection
1
1
Component Missing
1
1
Defective Device
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Material Too Rigid or Stiff
1
1
Self-Activation or Keying
1
1
Short Fill
1
1
Inadequacy of Device Shape and/or Size
1
1
Inadequate or Insufficient Training
1
1
Decreased Pump Speed
1
1
Material Puncture/Hole
1
1
Air/Gas in Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
202
202
Pressure Sores
90
90
No Clinical Signs, Symptoms or Conditions
68
68
Tissue Breakdown
30
30
Insufficient Information
20
20
No Consequences Or Impact To Patient
16
16
Pain
15
15
Ulcer
14
14
Bruise/Contusion
11
11
Bone Fracture(s)
10
10
Electric Shock
9
9
Skin Tears
8
8
No Known Impact Or Consequence To Patient
7
7
Head Injury
7
7
Laceration(s)
7
7
Death
6
6
Physical Entrapment
5
5
Localized Skin Lesion
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Injury
4
4
Hematoma
4
4
Pleural Effusion
4
4
Skin Erosion
4
4
Abrasion
4
4
Burn(s)
3
3
No Patient Involvement
3
3
Blister
3
3
Swelling/ Edema
2
2
Vertebral Fracture
2
2
Skin Infection
2
2
Joint Dislocation
2
2
Fungal Infection
2
2
Skull Fracture
2
2
Skin Discoloration
2
2
Swelling
1
1
Pneumonia
1
1
Contusion
1
1
Acoustic Shock
1
1
Headache
1
1
Fatigue
1
1
Neck Pain
1
1
Impaired Healing
1
1
Discomfort
1
1
Superficial (First Degree) Burn
1
1
No Code Available
1
1
Limb Fracture
1
1
Multiple Fractures
1
1
Skin Inflammation/ Irritation
1
1
Contact Dermatitis
1
1
Unspecified Tissue Injury
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Getinge (Suzhou) Co Ltd
II
Jun-04-2021
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