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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 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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