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TPLC
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Device
lift, patient, non-ac-powered
Product Code
FSA
Regulation Number
880.5510
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
367
367
2019
393
393
2020
281
281
2021
257
257
2022
264
264
2023
288
288
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
475
475
Break
263
263
Use of Device Problem
169
169
Unintended Movement
104
104
Device Tipped Over
89
89
Adverse Event Without Identified Device or Use Problem
83
83
Device Fell
78
78
Insufficient Information
75
75
Fracture
69
69
Material Split, Cut or Torn
53
53
Detachment Of Device Component
39
39
Mechanical Problem
30
30
Improper or Incorrect Procedure or Method
30
30
Appropriate Term/Code Not Available
30
30
Unstable
26
26
Unintended System Motion
21
21
Material Deformation
20
20
Device Handling Problem
19
19
Material Twisted/Bent
19
19
Material Rupture
19
19
Unclear Information
18
18
Installation-Related Problem
17
17
Device Dislodged or Dislocated
17
17
Material Separation
17
17
Component Missing
16
16
Naturally Worn
16
16
Sparking
15
15
Device Slipped
14
14
Crack
13
13
Loose or Intermittent Connection
12
12
Material Integrity Problem
12
12
Material Fragmentation
11
11
Inadequate or Insufficient Training
10
10
Defective Component
10
10
Positioning Failure
8
8
Therapeutic or Diagnostic Output Failure
8
8
Patient Device Interaction Problem
8
8
Protective Measures Problem
7
7
Fire
7
7
Electrical /Electronic Property Problem
6
6
Component Falling
6
6
No Apparent Adverse Event
6
6
Mechanical Jam
5
5
Misassembly by Users
5
5
Thermal Decomposition of Device
5
5
Disconnection
5
5
Collapse
5
5
Material Frayed
5
5
Overheating of Device
4
4
Misassembled
4
4
Smoking
4
4
Off-Label Use
4
4
Product Quality Problem
4
4
Battery Problem
4
4
Contamination /Decontamination Problem
4
4
Structural Problem
4
4
Defective Device
4
4
Mechanics Altered
4
4
Electrical Shorting
4
4
Sharp Edges
4
4
Fail-Safe Did Not Operate
4
4
Unintended Electrical Shock
3
3
Fail-Safe Problem
3
3
Human Factors Issue
3
3
Output Problem
3
3
Noise, Audible
3
3
Melted
3
3
Material Erosion
3
3
Circuit Failure
3
3
Component Incompatible
3
3
Accessory Incompatible
2
2
Entrapment of Device
2
2
Material Disintegration
2
2
Nonstandard Device
2
2
Device Emits Odor
2
2
Solder Joint Fracture
2
2
Tear, Rip or Hole in Device Packaging
2
2
Device Remains Activated
2
2
Failure to Power Up
2
2
Inadequacy of Device Shape and/or Size
2
2
Sticking
2
2
Microbial Contamination of Device
2
2
Scratched Material
2
2
Temperature Problem
2
2
Inadequate User Interface
2
2
Compatibility Problem
2
2
Failure to Shut Off
2
2
Flare or Flash
2
2
Device Operates Differently Than Expected
2
2
Device-Device Incompatibility
2
2
Component Misassembled
2
2
Misassembled During Installation
2
2
Incomplete or Inadequate Connection
2
2
Misassembly During Maintenance/Repair
2
2
Key or Button Unresponsive/not Working
2
2
Activation Problem
1
1
Physical Resistance/Sticking
1
1
Non Reproducible Results
1
1
Electrical Power Problem
1
1
Human-Device Interface Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
528
528
No Clinical Signs, Symptoms or Conditions
339
339
No Consequences Or Impact To Patient
233
233
Bone Fracture(s)
186
186
Head Injury
157
157
No Known Impact Or Consequence To Patient
124
124
Laceration(s)
123
123
Bruise/Contusion
116
116
No Patient Involvement
106
106
Pain
67
67
Death
56
56
Injury
54
54
Hematoma
47
47
Insufficient Information
32
32
Hip Fracture
29
29
Abrasion
28
28
Skin Tears
22
22
Hemorrhage/Bleeding
17
17
Concussion
14
14
Limb Fracture
14
14
Unspecified Tissue Injury
13
13
Fracture, Arm
13
13
No Information
10
10
Intracranial Hemorrhage
10
10
Multiple Fractures
10
10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
10
Swelling
9
9
Electric Shock
8
8
Muscle/Tendon Damage
8
8
Patient Problem/Medical Problem
7
7
Swelling/ Edema
7
7
Contusion
7
7
Physical Entrapment
6
6
Brain Injury
5
5
Sprain
5
5
Tooth Fracture
5
5
Vertebral Fracture
5
5
No Code Available
4
4
Headache
4
4
Bacterial Infection
4
4
Damage to Ligament(s)
4
4
Hemorrhage, Cerebral
4
4
Skull Fracture
3
3
Spinal Column Injury
3
3
Pneumothorax
3
3
Hemothorax
3
3
Ecchymosis
3
3
Neck Pain
3
3
Discomfort
3
3
Suture Abrasion
3
3
Post Traumatic Wound Infection
2
2
Joint Dislocation
2
2
Loss of consciousness
2
2
Confusion/ Disorientation
2
2
Pressure Sores
2
2
Chest Pain
2
2
Crushing Injury
2
2
Convulsion/Seizure
2
2
Suicidal Ideation
1
1
Superficial (First Degree) Burn
1
1
Blister
1
1
Localized Skin Lesion
1
1
Nodule
1
1
Fatigue
1
1
Hearing Impairment
1
1
Electrocution
1
1
Emotional Changes
1
1
Eye Injury
1
1
Hypersensitivity/Allergic reaction
1
1
Inflammation
1
1
Liver Laceration(s)
1
1
Muscle Weakness
1
1
Staphylococcus Aureus
1
1
Seizures
1
1
Anxiety
1
1
Joint Disorder
1
1
Strangulation
1
1
Abdominal Pain
1
1
Tissue Damage
1
1
Vomiting
1
1
Tingling
1
1
Blood Loss
1
1
Missing Value Reason
1
1
Spinal Cord Injury
1
1
Respiratory Failure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
I
May-21-2022
2
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
II
Mar-06-2020
3
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
II
Dec-07-2018
4
Arjohuntleigh Magog
II
Aug-07-2018
5
Arjohuntleigh Magog, Inc.
II
May-24-2023
6
Arjohuntleigh Magog, Inc.
II
Sep-16-2021
7
Arjohuntleigh Magog, Inc.
II
Feb-09-2021
8
Autochair
II
Apr-18-2018
9
Baxter Healthcare Corporation
II
Mar-28-2022
10
Community Products, LLC
II
Oct-22-2019
11
Getinge Dominican Republic SA
II
Sep-13-2021
12
Handicare AB
II
Oct-09-2020
13
Handicare AB
II
May-09-2020
14
Hill-Rom, Inc.
II
Mar-11-2022
15
Hill-Rom, Inc.
II
Feb-16-2022
16
Hill-Rom, Inc.
II
Sep-30-2021
17
Hill-Rom, Inc.
I
Jan-29-2021
18
Human Care USA, Inc.
II
Mar-31-2022
19
Invacare Corporation
II
Dec-03-2018
20
Liko AB
II
Oct-12-2018
21
Med-Mizer, Inc.
II
Mar-02-2023
22
Moller Vital
II
May-16-2019
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