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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 740 1227

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 982 982
No Audible Alarm 973 1170
Unintended Movement 905 924
Electrical /Electronic Property Problem 486 2770
Incorrect Measurement 472 3137
Mechanical Problem 419 1643
Detachment of Device or Device Component 402 402
Defective Alarm 361 361
Device Alarm System 356 356
Unintended System Motion 299 878
Use of Device Problem 227 227
Sharp Edges 169 291
Device Fell 154 248
Device Slipped 148 148
Intermittent Loss of Power 127 823
Break 113 113
Positioning Failure 109 171
Activation Problem 105 105
Adverse Event Without Identified Device or Use Problem 102 102
Appropriate Term/Code Not Available 88 88
Sparking 75 75
Unclear Information 71 71
Material Frayed 65 65
Insufficient Information 64 64
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 31 31
Positioning Problem 31 39
Communication or Transmission Problem 29 29
Collapse 27 27
Electrical Shorting 24 24
Patient Device Interaction Problem 24 24
Smoking 22 21
Pressure Problem 20 20
Defective Device 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
Inflation Problem 11 11
Improper or Incorrect Procedure or Method 11 11
Therapeutic or Diagnostic Output Failure 10 10
Material Integrity Problem 10 10
Failure to Sense 10 20
False Alarm 10 10
Unintended Collision 9 9
Fracture 9 9
Device Tipped Over 9 10
Alarm Not Visible 8 11
Deflation Problem 8 8
Arcing 7 7
Battery Problem 7 7
Mechanical Jam 7 8
Manufacturing, Packaging or Shipping Problem 6 6
Scratched Material 6 6
Noise, Audible 6 6
Melted 6 6
Unintended Electrical Shock 6 6
Overheating of Device 5 5
Fluid/Blood Leak 5 5
Delayed Alarm 5 5
Power Problem 5 5
Output Problem 5 5
Activation, Positioning or Separation Problem 5 5
Tear, Rip or Hole in Device Packaging 5 5
Radiofrequency Interference (RFI) 5 5
No Audible Prompt/Feedback 4 4
Structural Problem 4 4
Device Displays Incorrect Message 4 4
Device Damaged by Another Device 4 4
Flare or Flash 4 4
Patient-Device Incompatibility 4 4
Connection Problem 4 4
Wireless Communication Problem 4 4
Device Handling Problem 4 4
Activation Failure 4 4
Thermal Decomposition of Device 4 4
Crack 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
Unable to Obtain Readings 3 3
Component Misassembled 3 3
Installation-Related Problem 3 3
Naturally Worn 3 3
Human-Device Interface Problem 3 3
Measurement System Incompatibility 3 3
Deformation Due to Compressive Stress 3 3
Calibration Problem 3 3
Failure to Shut Off 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4613 9274
No Patient Involvement 1691 5017
Insufficient Information 370 370
Fall 313 388
No Consequences Or Impact To Patient 265 363
Pressure Sores 140 140
No Known Impact Or Consequence To Patient 91 91
Bone Fracture(s) 57 57
Laceration(s) 56 57
Pain 41 114
Death 30 30
Bruise/Contusion 29 33
Hip Fracture 29 29
Physical Entrapment 24 24
Unspecified Tissue Injury 20 20
Electric Shock 16 16
Head Injury 16 16
Abrasion 15 21
Injury 14 14
Hematoma 10 10
Burn(s) 8 8
Skin Tears 6 6
Shock 5 28
Cardiac Arrest 5 5
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
Bradycardia 4 4
Loss of consciousness 4 4
Decreased Respiratory Rate 3 3
Joint Dislocation 3 3
Low Oxygen Saturation 3 3
Erythema 3 3
Low Blood Pressure/ Hypotension 3 3
Unintended Extubation 3 3
No Code Available 3 3
Respiratory Arrest 2 2
Syncope/Fainting 2 2
Blister 2 2
Swelling/ Edema 2 2
Subluxation 2 2
Muscle/Tendon Damage 2 2
Patient Problem/Medical Problem 2 2
Hypersensitivity/Allergic reaction 2 2
Strangulation 2 2
Swelling 2 2
Hypoxia 2 2
Asphyxia 2 2
Crushing Injury 2 2
Respiratory Failure 2 2
Confusion/ Disorientation 2 2
Blood Loss 2 2
Tooth Fracture 2 2
Fracture, Arm 2 2
Neurological Deficit/Dysfunction 2 2
Discomfort 2 2
Skin Discoloration 2 2
Brain Injury 2 2
Ulcer 1 1
Distress 1 1
Anaphylactoid 1 1
Deformity/ Disfigurement 1 1
Spinal Cord Injury 1 1
Neck Pain 1 1
Post Traumatic Wound Infection 1 1
Choking 1 1
Weight Changes 1 1
Disc Impingement 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Laceration(s) of Esophagus 1 1
Numbness 1 1
Suture Abrasion 1 1
Sleep Dysfunction 1 1
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
Unspecified Musculoskeletal problem 1 1
Localized Skin Lesion 1 1
Skin Disorders 1 1
Contact Dermatitis 1 1
Easy Bruising 1 1
Unspecified Heart Problem 1 1
Aspiration Pneumonitis 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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