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TPLC
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show TPLC since
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2024
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Device
bed, pediatric open hospital
Product Code
FMS
Regulation Number
880.5140
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
157
157
2015
175
175
2016
137
137
2017
121
121
2018
113
113
2019
30
103
2020
28
139
2021
28
91
2022
22
91
2023
29
130
2024
5
32
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
194
194
Device Slipped
169
169
Device Operates Differently Than Expected
117
117
Mechanical Problem
50
50
Positioning Failure
46
349
Sticking
45
45
Device Fell
35
84
False Reading From Device Non-Compliance
30
30
Incorrect Measurement
26
70
Detachment Of Device Component
25
25
Loose or Intermittent Connection
23
23
Component Falling
22
22
Incorrect, Inadequate or Imprecise Result or Readings
17
17
Unintended Movement
17
17
Mechanics Altered
16
16
Positioning Problem
16
61
Scratched Material
15
15
Improper Device Output
13
13
Failure to Disconnect
13
13
Device Displays Incorrect Message
13
13
Naturally Worn
11
11
Mechanical Jam
11
12
Component Missing
10
10
Failure to Align
9
9
Unintended System Motion
9
9
Failure to Zero
9
9
Malposition of Device
8
8
Insufficient Information
8
8
Device Inoperable
7
7
Calibration Problem
6
6
Patient Device Interaction Problem
6
7
Defective Component
5
5
Output Problem
5
5
Material Integrity Problem
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Connection Problem
4
4
Unstable
4
4
Material Separation
4
4
Crack
4
4
Material Frayed
4
4
Disconnection
3
3
Bent
3
3
Delamination
3
3
Defective Device
3
3
Incorrect Or Inadequate Test Results
3
3
Human-Device Interface Problem
3
3
Sharp Edges
3
3
Device Dislodged or Dislocated
2
4
Detachment of Device or Device Component
2
2
Protective Measures Problem
2
2
Failure to Calibrate
2
2
Structural Problem
2
2
Battery Problem
2
2
Collapse
2
2
Peeled/Delaminated
2
2
Difficult To Position
2
2
Product Quality Problem
1
1
Failure to Recalibrate
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Misconnection
1
1
Use of Device Problem
1
1
Metal Shedding Debris
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Signal Artifact/Noise
1
1
Difficult or Delayed Positioning
1
1
Entrapment of Device
1
1
False Device Output
1
1
Imprecision
1
1
Device Tipped Over
1
1
Activation, Positioning or Separation Problem
1
1
Computer Operating System Problem
1
1
Low Battery
1
1
Cut In Material
1
1
High Readings
1
1
Low Readings
1
1
Measurement System Incompatibility
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Difficult to Open or Close
1
1
Fail-Safe Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Physical Resistance/Sticking
1
1
Appropriate Term/Code Not Available
1
1
Torn Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
534
534
No Consequences Or Impact To Patient
138
138
No Clinical Signs, Symptoms or Conditions
85
370
No Patient Involvement
52
220
Physical Entrapment
9
10
Fall
8
8
Insufficient Information
6
6
Injury
5
5
No Information
4
4
Bruise/Contusion
4
4
Swelling
3
3
Laceration(s)
2
2
Abrasion
2
3
Bone Fracture(s)
1
1
Head Injury
1
1
Pain
1
2
Concussion
1
1
Vertebral Fracture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
PediaLift LLC
II
Feb-02-2020
2
Stryker Medical Division of Stryker Corporation
II
Aug-06-2021
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