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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
Unintended Movement
12
12
Adverse Event Without Identified Device or Use Problem
12
12
Break
11
11
Positioning Failure
9
16
Electrical /Electronic Property Problem
8
8
No Audible Alarm
8
8
Mechanical Problem
7
7
Device Alarm System
6
6
Inflation Problem
6
6
Smoking
5
5
Fire
5
5
No Apparent Adverse Event
4
4
Device Slipped
4
4
Insufficient Information
4
4
Device Fell
4
4
Material Deformation
3
3
Use of Device Problem
3
3
Temperature Problem
3
3
Loose or Intermittent Connection
3
3
Unintended System Motion
2
2
Detachment of Device or Device Component
2
2
Defective Alarm
2
2
Self-Activation or Keying
2
2
Defective Component
2
2
Unintended Electrical Shock
2
2
Disconnection
2
2
Contamination /Decontamination Problem
1
1
Patient Device Interaction Problem
1
1
Mechanical Jam
1
1
Thermal Decomposition of Device
1
1
Structural Problem
1
1
Sharp Edges
1
1
Burst Container or Vessel
1
1
Material Fragmentation
1
1
Positioning Problem
1
1
Component Missing
1
1
Gas/Air Leak
1
1
Material Discolored
1
1
Material Integrity Problem
1
1
Calibration Problem
1
1
Electrical Shorting
1
1
Leak/Splash
1
1
Failure to Pump
1
1
Activation Failure
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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