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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bed, ac-powered adjustable hospital
Product CodeFNL
Regulation Number 880.5100
Device Class 2


Premarket Reviews
ManufacturerDecision
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 2137 3060

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 1642 1642
Unintended Movement 1082 1101
No Audible Alarm 1020 1227
Electrical /Electronic Property Problem 531 2999
Incorrect Measurement 504 3245
Detachment of Device or Device Component 466 466
Mechanical Problem 438 1693
Defective Alarm 365 365
Device Alarm System 358 358
Unintended System Motion 316 912
Use of Device Problem 252 252
Sharp Edges 181 314
Device Fell 171 278
Device Slipped 149 149
Intermittent Loss of Power 142 919
Activation Problem 132 132
Positioning Failure 127 202
Adverse Event Without Identified Device or Use Problem 116 116
Break 116 116
Appropriate Term/Code Not Available 98 98
Sparking 89 89
Unclear Information 71 71
Material Frayed 70 70
Insufficient Information 69 69
Defective Component 57 57
Self-Activation or Keying 47 47
No Apparent Adverse Event 43 45
Loose or Intermittent Connection 39 39
Fire 38 38
Circuit Failure 33 33
Communication or Transmission Problem 32 32
Positioning Problem 31 39
Collapse 28 28
Patient Device Interaction Problem 27 27
Smoking 26 25
Electrical Shorting 25 25
Pressure Problem 20 20
Intermittent Continuity 20 20
Defective Device 20 20
Electromagnetic Interference 18 18
Material Twisted/Bent 16 16
Inflation Problem 14 14
Component Missing 14 14
Entrapment of Device 14 14
Protective Measures Problem 14 14
Physical Resistance/Sticking 14 14
Fracture 13 13
Arcing 11 11
Improper or Incorrect Procedure or Method 11 11
False Alarm 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5892 10989
No Patient Involvement 1691 5017
Insufficient Information 411 411
Fall 355 440
No Consequences Or Impact To Patient 265 363
Pressure Sores 147 147
No Known Impact Or Consequence To Patient 91 91
Laceration(s) 64 68
Bone Fracture(s) 63 63
Pain 45 118
Bruise/Contusion 32 36
Hip Fracture 31 31
Physical Entrapment 30 30
Death 30 30
Unspecified Tissue Injury 23 23
Head Injury 21 21
Abrasion 18 24
Electric Shock 17 17
Hematoma 15 15
Injury 14 14
Burn(s) 8 8
Cardiac Arrest 8 8
Hemorrhage/Bleeding 7 7
Limb Fracture 6 6
Skin Tears 6 6
Shock 5 28
Hemorrhage, Subdural 5 5
Bradycardia 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Joint Dislocation 4 4
Discomfort 4 4
Skull Fracture 4 4
Loss of consciousness 4 4
Muscle/Tendon Damage 3 3
Erythema 3 3
Skin Discoloration 3 3
Blister 3 3
Unspecified Infection 3 3
Multiple Fractures 3 3
Unintended Extubation 3 3
Low Blood Pressure/ Hypotension 3 3
Brain Injury 3 3
No Code Available 3 3
Low Oxygen Saturation 3 3
Decreased Respiratory Rate 3 3
Respiratory Arrest 3 3
Subluxation 2 2
Fracture, Arm 2 2
Patient Problem/Medical Problem 2 2
Syncope/Fainting 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 Oct-25-2024
5 Baxter Healthcare Corporation II Jun-26-2023
6 Baxter Healthcare Corporation II Nov-14-2022
7 Baxter Healthcare Corporation I Oct-31-2022
8 Hill-Rom, Inc. II Jul-30-2020
9 Hill-Rom, Inc. II Jun-03-2020
10 Linet Spol. S.r.o. II Jan-04-2021
11 Oakworks Inc II Jun-06-2022
12 Stryker Medical Division of Stryker Corporation II Dec-01-2023
13 Stryker Medical Division of Stryker Corporation II Aug-06-2021
14 Umano Medical, Inc. II May-26-2022
15 Umano Medical, Inc. II Jun-02-2020
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