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TPLC
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show TPLC since
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2024
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Device
stretcher, wheeled, powered
Product Code
INK
Regulation Number
890.3690
Device Class
2
Premarket Reviews
Manufacturer
Decision
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L
SUBSTANTIALLY EQUIVALENT
1
HILL-ROM CO.
SUBSTANTIALLY EQUIVALENT
1
STRYKER CORPORATION
SUBSTANTIALLY EQUIVALENT
1
1. K140095
PRIME ZOOM STRETCHER
TRANSMOTION MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
WINCO MANUFACTURING LLC
SUBSTANTIALLY EQUIVALENT
1
WINCO MFG., LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
88
88
2015
4
4
2016
5
5
2017
5
5
2018
63
146
2019
79
328
2020
89
295
2021
114
308
2022
93
393
2023
147
527
2024
26
132
Device Problems
MDRs with this Device Problem
Events in those MDRs
Intermittent Loss of Power
121
507
Mechanical Jam
89
276
Unintended System Motion
89
480
Electrical /Electronic Property Problem
85
255
Grounding Malfunction
60
153
Mechanical Problem
57
147
Break
48
48
Device Slipped
37
40
Positioning Problem
32
34
Unintended Movement
31
88
Fluid/Blood Leak
26
150
Sharp Edges
25
37
Device Stops Intermittently
18
21
Positioning Failure
14
16
Device Inoperable
13
13
Insufficient Information
11
11
Device Fell
10
10
Device Operates Differently Than Expected
8
8
Naturally Worn
5
5
Patient Device Interaction Problem
5
5
Defective Component
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Scratched Material
3
3
Unintended Electrical Shock
2
2
Improper or Incorrect Procedure or Method
2
2
Sticking
2
2
Fire
2
2
Peeled/Delaminated
2
2
Loss of Power
1
1
Material Separation
1
1
Kinked
1
1
Leak/Splash
1
1
Loose or Intermittent Connection
1
1
Incorrect Measurement
1
1
False Reading From Device Non-Compliance
1
1
Crack
1
1
No Audible Alarm
1
1
Bent
1
1
Loss of or Failure to Bond
1
1
Use of Device Problem
1
1
Smoking
1
1
Migration or Expulsion of Device
1
1
Component Missing
1
1
Failure to Align
1
1
Arcing
1
1
Defective Device
1
1
Malposition of Device
1
1
Battery Problem
1
1
Communication or Transmission Problem
1
1
Connection Problem
1
1
Physical Resistance/Sticking
1
1
No Apparent Adverse Event
1
1
Device Contamination with Chemical or Other Material
1
1
Material Integrity Problem
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
356
1404
No Patient Involvement
188
670
No Known Impact Or Consequence To Patient
84
86
Insufficient Information
38
55
Pain
17
24
Injury
17
17
No Consequences Or Impact To Patient
9
21
Muscle/Tendon Damage
9
25
Laceration(s)
8
8
Fall
7
11
Electric Shock
6
12
Bruise/Contusion
5
20
Bone Fracture(s)
2
2
Shock
2
4
Sprain
1
1
Concussion
1
1
Head Injury
1
1
Fatigue
1
1
Neck Pain
1
1
Muscle Spasm(s)
1
1
Physical Entrapment
1
1
Discomfort
1
5
Unspecified Musculoskeletal problem
1
4
No Information
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Medical Div. of Stryker Corporation
II
Aug-09-2010
2
Stryker Medical Division of Stryker Corporation
II
Jun-01-2020
3
Stryker Medical Division of Stryker Corporation
II
Mar-17-2016
4
Stryker Medical Division of Stryker Corporation
II
Aug-03-2011
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