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TPLC
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show TPLC since
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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
64
64
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
156
156
Insufficient Information
74
74
Deflation Problem
61
61
Sparking
23
23
Dent in Material
21
21
Use of Device Problem
20
20
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 Shorting
10
10
Electrical /Electronic Property Problem
10
10
Infusion or Flow Problem
8
8
Detachment of Device or Device Component
7
7
Fire
7
7
Unintended Electrical Shock
7
7
Pressure Problem
6
6
Decrease in Pressure
5
5
Device Slipped
5
5
Malposition of Device
4
4
Mechanical Problem
4
4
Difficult or Delayed Positioning
4
4
Patient Device Interaction Problem
4
4
Protective Measures Problem
3
3
No Pressure
3
3
Device-Device Incompatibility
3
3
Installation-Related Problem
3
3
Smoking
3
3
Product Quality Problem
3
3
Self-Activation or Keying
2
2
Defective Component
2
2
Disconnection
2
2
Thermal Decomposition of Device
2
2
Circuit Failure
2
2
Use of Incorrect Control/Treatment Settings
2
2
Gas/Air Leak
2
2
Contamination /Decontamination Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Complete Loss of Power
2
2
Sharp Edges
2
2
Device Fell
1
1
Component Misassembled
1
1
Material Split, Cut or Torn
1
1
Noise, Audible
1
1
Pumping Problem
1
1
Positioning Problem
1
1
Power Problem
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Device Dislodged or Dislocated
1
1
Device Damaged by Another Device
1
1
Improper Flow or Infusion
1
1
Flare or Flash
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Protrusion/Extrusion
1
1
Material Twisted/Bent
1
1
Crack
1
1
Device Alarm System
1
1
Inability to Auto-Fill
1
1
Melted
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
Obstruction of Flow
1
1
Defective Device
1
1
Short Fill
1
1
Inadequacy of Device Shape and/or Size
1
1
Inadequate or Insufficient Training
1
1
Material Too Rigid or Stiff
1
1
Decreased Pump Speed
1
1
Material Puncture/Hole
1
1
Inaccurate Information
1
1
Unclear Information
1
1
Air/Gas in Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
204
204
Pressure Sores
105
105
No Clinical Signs, Symptoms or Conditions
77
77
Tissue Breakdown
30
30
Insufficient Information
21
21
No Consequences Or Impact To Patient
16
16
Ulcer
15
15
Skin Tears
15
15
Pain
15
15
Bruise/Contusion
11
11
Bone Fracture(s)
10
10
Electric Shock
9
9
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
Skin Discoloration
2
2
Vertebral Fracture
2
2
Skin Infection
2
2
Joint Dislocation
2
2
Fungal Infection
2
2
Skull Fracture
2
2
Swelling
1
1
Pneumonia
1
1
Unspecified Infection
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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