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TPLC
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show TPLC since
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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
2019
22
22
2020
15
15
2021
30
39
2022
37
51
2023
176
185
2024
156
167
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
202
202
Activation Problem
38
38
Sparking
36
36
Material Frayed
21
21
Incorrect Measurement
14
50
Appropriate Term/Code Not Available
14
14
Adverse Event Without Identified Device or Use Problem
12
12
Unintended Movement
12
12
Break
11
11
Positioning Failure
9
16
No Audible Alarm
8
8
Electrical /Electronic Property Problem
8
8
Mechanical Problem
7
7
Inflation Problem
6
6
Device Alarm System
6
6
Fire
5
5
Smoking
5
5
No Apparent Adverse Event
4
4
Device Slipped
4
4
Device Fell
4
4
Insufficient Information
4
4
Temperature Problem
3
3
Use of Device Problem
3
3
Loose or Intermittent Connection
3
3
Material Deformation
3
3
Defective Component
2
2
Defective Alarm
2
2
Unintended Electrical Shock
2
2
Unintended System Motion
2
2
Detachment of Device or Device Component
2
2
Disconnection
2
2
Self-Activation or Keying
2
2
Connection Problem
1
1
Melted
1
1
Material Separation
1
1
Product Quality Problem
1
1
Intermittent Continuity
1
1
Activation Failure
1
1
Failure to Pump
1
1
Electrical Shorting
1
1
Mechanical Jam
1
1
Calibration Problem
1
1
Thermal Decomposition of Device
1
1
Sharp Edges
1
1
Structural Problem
1
1
Pressure Problem
1
1
Leak/Splash
1
1
Activation, Positioning or Separation Problem
1
1
Material Integrity Problem
1
1
Positioning Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
330
373
Insufficient Information
25
25
No Patient Involvement
18
18
Pressure Sores
13
13
Fall
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Electric Shock
5
5
Laceration(s)
5
5
Unspecified Tissue Injury
5
5
Pain
4
4
Strangulation
2
2
No Consequences Or Impact To Patient
2
2
Hip Fracture
1
1
Death
1
1
Sepsis
1
1
No Information
1
1
Necrosis
1
1
Bone Fracture(s)
1
1
Abrasion
1
1
Localized Skin Lesion
1
1
No Known Impact Or Consequence To Patient
1
1
Injury
1
1
Burn(s)
1
1
Discomfort
1
1
Dyspnea
1
1
Shock
1
1
Skin Tears
1
1
Erosion
1
1
Low Oxygen Saturation
1
1
Bruise/Contusion
1
1
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