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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 495 722

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 961 1152
Material Split, Cut or Torn 888 888
Unintended Movement 874 893
Electrical /Electronic Property Problem 460 2618
Incorrect Measurement 458 3091
Mechanical Problem 411 1612
Detachment of Device or Device Component 393 393
Defective Alarm 361 361
Device Alarm System 356 356
Unintended System Motion 293 870
Use of Device Problem 220 220
Sharp Edges 159 269
Device Slipped 148 148
Device Fell 146 230
Intermittent Loss of Power 121 771
Break 113 113
Activation Problem 103 103
Adverse Event Without Identified Device or Use Problem 102 102
Positioning Failure 99 158
Appropriate Term/Code Not Available 88 88
Sparking 75 75
Unclear Information 71 71
Insufficient Information 63 63
Material Frayed 63 63
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 30 38
Communication or Transmission Problem 29 29
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
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
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
Device Dislodged or Dislocated 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4380 8781
No Patient Involvement 1691 5017
Insufficient Information 368 368
Fall 307 382
No Consequences Or Impact To Patient 265 363
Pressure Sores 139 139
No Known Impact Or Consequence To Patient 91 91
Laceration(s) 56 57
Bone Fracture(s) 53 53
Pain 41 114
Death 30 30
Hip Fracture 29 29
Bruise/Contusion 28 32
Physical Entrapment 24 24
Unspecified Tissue Injury 20 20
Electric Shock 16 16
Abrasion 15 21
Head Injury 15 15
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
Low Oxygen Saturation 3 3
Decreased Respiratory Rate 3 3
Joint Dislocation 3 3
Erythema 3 3
Low Blood Pressure/ Hypotension 3 3
Unintended Extubation 3 3
No Code Available 3 3
Syncope/Fainting 2 2
Confusion/ Disorientation 2 2
Patient Problem/Medical Problem 2 2
Subluxation 2 2
Muscle/Tendon Damage 2 2
Respiratory Arrest 2 2
Swelling/ Edema 2 2
Blister 2 2
Hypersensitivity/Allergic reaction 2 2
Strangulation 2 2
Swelling 2 2
Hypoxia 2 2
Asphyxia 2 2
Crushing Injury 2 2
Fracture, Arm 2 2
Neurological Deficit/Dysfunction 2 2
Brain Injury 2 2
Skin Discoloration 2 2
Respiratory Failure 2 2
Tooth Fracture 2 2
Blood Loss 2 2
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
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
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
Localized Skin Lesion 1 1
Skin Disorders 1 1
Contact Dermatitis 1 1
Easy Bruising 1 1
Unspecified Respiratory Problem 1 1
Unspecified Gastrointestinal Problem 1 1
Renal Impairment 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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