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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
95
105
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
167
167
Break
77
77
Bent
46
46
Device Slipped
45
45
Sparking
42
42
Device Operates Differently Than Expected
26
26
Mechanical Problem
26
26
Activation Problem
26
26
Material Frayed
24
24
Smoking
24
24
Unintended Movement
20
20
Adverse Event Without Identified Device or Use Problem
18
18
Unintended System Motion
17
17
Fire
14
14
Incorrect Measurement
13
48
Electrical /Electronic Property Problem
13
13
Appropriate Term/Code Not Available
11
11
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
Inflation Problem
7
7
Loose or Intermittent Connection
7
7
Component Falling
6
6
Noise, Audible
6
6
Insufficient Information
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
Mechanics Altered
3
3
Material Integrity Problem
3
3
Device Emits Odor
3
3
Melted
3
3
Collapse
3
3
Defective Alarm
3
3
Detachment of Device or Device Component
3
3
Electrical Shorting
3
3
Device Inoperable
3
3
Defective Component
3
3
Split
2
2
Arcing
2
2
Malposition of Device
2
2
Device Dislodged or Dislocated
2
2
Out-Of-Box Failure
2
2
Material Separation
2
2
Improper or Incorrect Procedure or Method
2
2
Peeled/Delaminated
2
2
Loss of Power
2
2
Material Fragmentation
2
2
Disconnection
2
2
Human Factors Issue
2
2
Human-Device Interface Problem
2
2
Naturally Worn
2
2
Mechanical Jam
2
2
Torn Material
2
2
Pressure Problem
2
2
Unintended Electrical Shock
2
2
Sharp Edges
2
2
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
Misassembled
1
1
Nonstandard Device
1
1
Overheating of Device
1
1
Low Audible Alarm
1
1
Burst Container or Vessel
1
1
Circuit Failure
1
1
Intermittent Continuity
1
1
Material Discolored
1
1
Entrapment of Device
1
1
Failure to Pump
1
1
Product Quality Problem
1
1
Device Remains Activated
1
1
Device Stops Intermittently
1
1
Inadequate or Insufficient Training
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Malfunction
1
1
Structural Problem
1
1
Failure to Align
1
1
Flare or Flash
1
1
Gas/Air Leak
1
1
Activation, Positioning or Separation Problem
1
1
Device-Device Incompatibility
1
1
Patient-Device Incompatibility
1
1
Calibration Problem
1
1
Contamination /Decontamination Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
275
317
No Known Impact Or Consequence To Patient
205
205
No Information
49
49
Insufficient Information
25
25
No Patient Involvement
23
23
Fall
23
23
No Consequences Or Impact To Patient
22
22
Pressure Sores
12
12
Electric Shock
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Laceration(s)
6
6
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
Strangulation
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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