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TPLC
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show TPLC since
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Device
bed, ac-powered adjustable hospital
Product Code
FNL
Regulation Number
880.5100
Device Class
2
Premarket Reviews
Manufacturer
Decision
STRYKER CORPORATION
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1113
3114
2020
1106
2854
2021
1377
2904
2022
1118
2243
2023
2188
3258
2024
1474
2168
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Split, Cut or Torn
1377
1377
No Audible Alarm
1000
1202
Unintended Movement
984
1003
Electrical /Electronic Property Problem
511
2888
Incorrect Measurement
489
3187
Detachment of Device or Device Component
445
445
Mechanical Problem
431
1671
Defective Alarm
363
363
Device Alarm System
356
356
Unintended System Motion
309
896
Use of Device Problem
243
243
Sharp Edges
176
302
Device Fell
163
263
Device Slipped
149
149
Intermittent Loss of Power
134
870
Positioning Failure
119
183
Activation Problem
118
118
Break
113
113
Adverse Event Without Identified Device or Use Problem
107
107
Appropriate Term/Code Not Available
94
94
Sparking
81
81
Unclear Information
71
71
Material Frayed
68
68
Insufficient Information
66
66
Defective Component
56
56
Self-Activation or Keying
47
47
No Apparent Adverse Event
40
42
Loose or Intermittent Connection
39
39
Fire
36
36
Positioning Problem
31
39
Circuit Failure
31
31
Communication or Transmission Problem
30
30
Patient Device Interaction Problem
28
28
Collapse
27
27
Smoking
25
24
Electrical Shorting
24
24
Intermittent Continuity
20
20
Pressure Problem
20
20
Defective Device
20
20
Electromagnetic Interference
18
18
Material Twisted/Bent
16
16
Protective Measures Problem
14
14
Component Missing
14
14
Physical Resistance/Sticking
14
14
Entrapment of Device
14
14
Inflation Problem
13
13
Improper or Incorrect Procedure or Method
11
11
Fracture
11
11
False Alarm
10
10
Failure to Sense
10
20
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5281
10149
No Patient Involvement
1691
5017
Insufficient Information
390
390
Fall
335
417
No Consequences Or Impact To Patient
265
363
Pressure Sores
143
143
No Known Impact Or Consequence To Patient
91
91
Laceration(s)
62
63
Bone Fracture(s)
60
60
Pain
42
115
Bruise/Contusion
32
36
Death
30
30
Hip Fracture
29
29
Physical Entrapment
25
25
Unspecified Tissue Injury
23
23
Head Injury
19
19
Abrasion
17
23
Electric Shock
16
16
Injury
14
14
Hematoma
12
12
Burn(s)
8
8
Hemorrhage/Bleeding
7
7
Cardiac Arrest
6
6
Skin Tears
6
6
Shock
5
28
Limb Fracture
5
5
Hemorrhage, Subdural
5
5
Skull Fracture
4
4
Bradycardia
4
4
Joint Dislocation
4
4
Loss of consciousness
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Muscle/Tendon Damage
3
3
No Code Available
3
3
Brain Injury
3
3
Low Blood Pressure/ Hypotension
3
3
Low Oxygen Saturation
3
3
Erythema
3
3
Decreased Respiratory Rate
3
3
Unintended Extubation
3
3
Skin Discoloration
3
3
Unspecified Infection
3
3
Swelling/ Edema
2
2
Subluxation
2
2
Hypoxia
2
2
Partial thickness (Second Degree) Burn
2
2
Asphyxia
2
2
Respiratory Failure
2
2
Discomfort
2
2
Swelling
2
2
Recalls
Manufacturer
Recall Class
Date Posted
1
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
II
Dec-22-2023
2
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
II
Sep-29-2021
3
ARJOHUNTLEIGH POLSKA Sp. z.o.o.
II
Aug-18-2020
4
Baxter Healthcare Corporation
II
Jun-26-2023
5
Baxter Healthcare Corporation
II
Nov-14-2022
6
Baxter Healthcare Corporation
I
Oct-31-2022
7
Hill-Rom, Inc.
II
Jul-30-2020
8
Hill-Rom, Inc.
II
Jun-03-2020
9
Linet Spol. S.r.o.
II
Jan-04-2021
10
Oakworks Inc
II
Jun-06-2022
11
Stryker Medical Division of Stryker Corporation
II
Dec-01-2023
12
Stryker Medical Division of Stryker Corporation
II
Aug-06-2021
13
Umano Medical, Inc.
II
May-26-2022
14
Umano Medical, Inc.
II
Jun-02-2020
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