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TPLC
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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
338
567
Device Problems
MDRs with this Device Problem
Events in those MDRs
No Audible Alarm
958
1149
Unintended Movement
842
861
Material Split, Cut or Torn
805
805
Electrical /Electronic Property Problem
460
2619
Incorrect Measurement
458
3091
Mechanical Problem
409
1610
Detachment of Device or Device Component
380
380
Defective Alarm
360
360
Device Alarm System
351
351
Unintended System Motion
293
870
Use of Device Problem
220
220
Sharp Edges
159
269
Device Slipped
148
148
Device Fell
145
230
Intermittent Loss of Power
121
771
Break
113
113
Adverse Event Without Identified Device or Use Problem
102
102
Activation Problem
101
101
Positioning Failure
99
158
Appropriate Term/Code Not Available
85
85
Sparking
73
73
Unclear Information
71
71
Insufficient Information
63
63
Material Frayed
60
60
Defective Component
56
56
Self-Activation or Keying
47
47
No Apparent Adverse Event
40
42
Loose or Intermittent Connection
39
39
Fire
35
35
Circuit Failure
30
30
Positioning Problem
30
38
Communication or Transmission Problem
27
27
Collapse
27
27
Patient Device Interaction Problem
24
24
Electrical Shorting
23
23
Smoking
22
21
Defective Device
20
20
Pressure Problem
20
20
Intermittent Continuity
19
19
Electromagnetic Interference
18
18
Material Twisted/Bent
16
16
Protective Measures Problem
14
14
Physical Resistance/Sticking
14
14
Component Missing
13
13
Entrapment of Device
13
13
Improper or Incorrect Procedure or Method
11
11
Inflation Problem
11
11
Failure to Sense
10
20
False Alarm
10
10
Therapeutic or Diagnostic Output Failure
10
10
Material Integrity Problem
10
10
Device Tipped Over
9
10
Unintended Collision
9
9
Alarm Not Visible
8
11
Deflation Problem
8
8
Fracture
7
7
Arcing
7
7
Mechanical Jam
7
8
Manufacturing, Packaging or Shipping Problem
6
6
Scratched Material
6
6
Noise, Audible
6
6
Battery Problem
6
6
Melted
6
6
Unintended Electrical Shock
6
6
Overheating of Device
5
5
Fluid/Blood Leak
5
5
Delayed Alarm
5
5
Activation, Positioning or Separation Problem
5
5
Radiofrequency Interference (RFI)
5
5
Tear, Rip or Hole in Device Packaging
5
5
Output Problem
5
5
Wireless Communication Problem
4
4
No Audible Prompt/Feedback
4
4
Structural Problem
4
4
Device Displays Incorrect Message
4
4
Patient-Device Incompatibility
4
4
Connection Problem
4
4
Device Damaged by Another Device
4
4
Flare or Flash
4
4
Crack
4
4
Thermal Decomposition of Device
4
4
Grounding Malfunction
4
4
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Inaccurate Information
4
4
Unintended Deflation
3
3
Key or Button Unresponsive/not Working
3
3
Complete Loss of Power
3
3
Product Quality Problem
3
3
Human-Device Interface Problem
3
3
Deformation Due to Compressive Stress
3
3
Device Handling Problem
3
3
Component Misassembled
3
3
Installation-Related Problem
3
3
Measurement System Incompatibility
3
3
Naturally Worn
3
3
Power Problem
3
3
No Fail-Safe Mechanism
2
2
Device Dislodged or Dislocated
2
2
Material Deformation
2
2
Activation Failure
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4235
8638
No Patient Involvement
1691
5017
Insufficient Information
366
366
Fall
300
375
No Consequences Or Impact To Patient
265
363
Pressure Sores
138
138
No Known Impact Or Consequence To Patient
91
91
Laceration(s)
56
57
Bone Fracture(s)
52
52
Pain
41
114
Death
30
30
Bruise/Contusion
28
32
Hip Fracture
27
27
Physical Entrapment
23
23
Unspecified Tissue Injury
20
20
Electric Shock
16
16
Injury
14
14
Abrasion
14
20
Head Injury
14
14
Hematoma
10
10
Burn(s)
8
8
Skin Tears
6
6
Shock
5
28
Hemorrhage/Bleeding
5
5
Hemorrhage, Subdural
5
5
Limb Fracture
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Skull Fracture
4
4
Cardiac Arrest
4
4
Bradycardia
4
4
Erythema
3
3
Low Blood Pressure/ Hypotension
3
3
Joint Dislocation
3
3
Loss of consciousness
3
3
Low Oxygen Saturation
3
3
Decreased Respiratory Rate
3
3
Unintended Extubation
3
3
No Code Available
3
3
Blister
2
2
Confusion/ Disorientation
2
2
Patient Problem/Medical Problem
2
2
Syncope/Fainting
2
2
Swelling/ Edema
2
2
Subluxation
2
2
Muscle/Tendon Damage
2
2
Respiratory Failure
2
2
Tooth Fracture
2
2
Blood Loss
2
2
Fracture, Arm
2
2
Neurological Deficit/Dysfunction
2
2
Brain Injury
2
2
Skin Discoloration
2
2
Hypersensitivity/Allergic reaction
2
2
Strangulation
2
2
Swelling
2
2
Hypoxia
2
2
Asphyxia
2
2
Crushing Injury
2
2
Adult Respiratory Distress Syndrome
1
1
Aspiration/Inhalation
1
1
Cardiopulmonary Arrest
1
1
Cellulitis
1
1
Stroke/CVA
1
1
Hair Loss
1
1
Exsanguination
1
1
Ecchymosis
1
1
Emotional Changes
1
1
Failure of Implant
1
1
Unspecified Infection
1
1
Damage to Ligament(s)
1
1
Tissue Damage
1
1
Hypovolemic Shock
1
1
Hemorrhage, Subarachnoid
1
1
Headache
1
1
Hearing Impairment
1
1
Anaphylactoid
1
1
Distress
1
1
Discomfort
1
1
Ulcer
1
1
Deformity/ Disfigurement
1
1
Laceration(s) of Esophagus
1
1
Numbness
1
1
Weight Changes
1
1
Sleep Dysfunction
1
1
Disc Impingement
1
1
Tissue Breakdown
1
1
Foreign Body In Patient
1
1
Spinal Cord Injury
1
1
Neck Pain
1
1
Post Traumatic Wound Infection
1
1
Choking
1
1
Suture Abrasion
1
1
Unspecified Musculoskeletal problem
1
1
Unspecified Heart Problem
1
1
Respiratory Arrest
1
1
Unspecified Respiratory Problem
1
1
Unspecified Gastrointestinal Problem
1
1
Renal Impairment
1
1
Menorrhagia
1
1
Partial thickness (Second Degree) Burn
1
1
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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