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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
2018 1214 2354
2019 1113 3114
2020 1106 2854
2021 1377 2904
2022 1118 2243
2023 1940 3020

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 984 1181
Unintended Movement 842 945
Device Alarm System 589 589
Incorrect Measurement 542 3648
Material Split, Cut or Torn 538 538
Electrical /Electronic Property Problem 509 2716
Mechanical Problem 465 1892
Defective Alarm 373 373
Detachment of Device or Device Component 358 358
Unintended System Motion 325 969
Use of Device Problem 238 292
Device Slipped 234 245
Break 189 189
Sharp Edges 156 260
Device Fell 156 238
Adverse Event Without Identified Device or Use Problem 135 135
Intermittent Loss of Power 119 770
Positioning Failure 98 152
Activation Problem 87 87
Appropriate Term/Code Not Available 87 87
Unclear Information 71 71
Self-Activation or Keying 70 70
Sparking 70 70
Insufficient Information 69 69
Defective Component 61 61
Material Frayed 47 47
Collapse 45 45
Loose or Intermittent Connection 41 41
Component Missing 40 40
No Apparent Adverse Event 39 41
Fire 36 36
Positioning Problem 33 41
Circuit Failure 30 30
Device Operates Differently Than Expected 30 30
Communication or Transmission Problem 28 28
Smoking 25 24
Failure to Zero 25 25
Improper or Incorrect Procedure or Method 24 24
Defective Device 23 23
Patient Device Interaction Problem 22 22
Material Twisted/Bent 21 21
Electrical Shorting 20 20
Pressure Problem 20 20
Intermittent Continuity 19 19
Electromagnetic Interference 18 18
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Alarm Not Visible 17 23
Protective Measures Problem 15 15
Physical Resistance/Sticking 15 15
Entrapment of Device 14 14
Unintended Head Motion 13 13
Failure to Sense 13 25
Inflation Problem 11 11
Device Displays Incorrect Message 11 11
Scratched Material 11 11
Therapeutic or Diagnostic Output Failure 10 10
Device Tipped Over 10 11
Calibration Problem 10 10
False Alarm 10 10
Deflation Problem 9 9
Unintended Collision 9 9
Peeled/Delaminated 9 13
Material Integrity Problem 9 9
Arcing 9 9
Output Problem 9 9
Device Inoperable 8 8
Human Factors Issue 8 8
Mechanical Jam 7 8
Battery Problem 7 7
Melted 7 7
Thermal Decomposition of Device 7 7
Noise, Audible 7 7
Unintended Electrical Shock 6 6
Bent 6 6
Fluid/Blood Leak 6 6
False Reading From Device Non-Compliance 6 6
Overheating of Device 6 6
Activation, Positioning or Separation Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Material Deformation 6 6
Unstable 6 6
Radiofrequency Interference (RFI) 5 5
Inaudible or Unclear Audible Prompt/Feedback 5 5
Tear, Rip or Hole in Device Packaging 5 5
Flare or Flash 5 5
Connection Problem 5 5
Fracture 5 5
Delayed Alarm 5 5
Detachment Of Device Component 4 4
Crack 4 4
Device Emits Odor 4 4
Grounding Malfunction 4 4
Human-Device Interface Problem 4 6
Naturally Worn 4 4
Failure to Calibrate 4 4
Cut In Material 4 4
Structural Problem 4 4
Malposition of Device 4 4
Patient-Device Incompatibility 4 4
No Audible Prompt/Feedback 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3695 7879
No Patient Involvement 2102 6568
No Known Impact Or Consequence To Patient 572 627
No Consequences Or Impact To Patient 489 762
Insufficient Information 361 361
Fall 344 418
Pressure Sores 137 137
Laceration(s) 62 63
Bone Fracture(s) 59 59
Pain 44 117
Death 40 40
Injury 33 33
Hip Fracture 28 28
Bruise/Contusion 26 28
Physical Entrapment 25 25
Abrasion 19 23
Unspecified Tissue Injury 19 19
Electric Shock 17 17
Head Injury 14 14
Hematoma 11 11
Burn(s) 8 8
Hemorrhage/Bleeding 5 5
Hemorrhage, Subdural 5 5
Shock 5 28
Skull Fracture 5 5
Skin Tears 5 5
No Information 5 5
Limb Fracture 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 4 4
Low Oxygen Saturation 4 4
Joint Dislocation 4 4
Bradycardia 4 4
Crushing Injury 3 3
Asphyxia 3 3
Erythema 3 3
Cardiac Arrest 3 3
Low Blood Pressure/ Hypotension 3 3
Fracture, Arm 3 3
Decreased Respiratory Rate 3 3
Discomfort 3 3
Brain Injury 3 3
Unintended Extubation 3 3
Patient Problem/Medical Problem 2 2
Blister 2 2
Syncope/Fainting 2 2
Blood Loss 2 2
Choking 2 2
Confusion/ Disorientation 2 2
Disc Impingement 2 2
Neurological Deficit/Dysfunction 2 2
Strangulation 2 2
Swelling 2 2
Skin Discoloration 2 2
Loss of consciousness 2 2
Tooth Fracture 2 2
Neck Pain 2 2
Hypersensitivity/Allergic reaction 2 2
Hypoxia 2 2
Failure of Implant 1 1
Unspecified Infection 1 1
Damage to Ligament(s) 1 1
Hypovolemic Shock 1 1
Hemorrhage, Cerebral 1 1
Hemorrhage, Subarachnoid 1 1
Headache 1 1
Hearing Impairment 1 1
Hair Loss 1 1
Cardiopulmonary Arrest 1 1
Cellulitis 1 1
Stroke/CVA 1 1
Adult Respiratory Distress Syndrome 1 1
Aspiration/Inhalation 1 1
Bacterial Infection 1 1
Exsanguination 1 1
Ecchymosis 1 1
Emotional Changes 1 1
Post Traumatic Wound Infection 1 1
Spinal Cord Injury 1 1
Suture Abrasion 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Deformity/ Disfigurement 1 1
Ventilator Dependent 1 1
Laceration(s) of Esophagus 1 1
Extubate 1 1
Numbness 1 1
Respiratory Distress 1 1
Tissue Damage 1 1
Distress 1 1
Ulcer 1 1
Anaphylactoid 1 1
Tissue Breakdown 1 1
Foreign Body In Patient 1 1
Weight Changes 1 1
Unspecified Heart Problem 1 1
Unspecified Gastrointestinal Problem 1 1
Renal Impairment 1 1
Menorrhagia 1 1
Convulsion/Seizure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Sep-29-2021
2 ARJOHUNTLEIGH POLSKA Sp. z.o.o. II Aug-18-2020
3 Baxter Healthcare Corporation II Jun-26-2023
4 Baxter Healthcare Corporation II Nov-14-2022
5 Baxter Healthcare Corporation I Oct-31-2022
6 Handicare Usa Inc II Aug-20-2018
7 Hill-Rom, Inc. II Jul-30-2020
8 Hill-Rom, Inc. II Jun-03-2020
9 Hill-Rom, Inc. II Apr-09-2018
10 Linet Spol. S.r.o. II Jan-04-2021
11 Med-Mizer, Inc. II Sep-17-2018
12 Oakworks Inc II Jun-06-2022
13 Stryker Medical Division of Stryker Corporation II Dec-01-2023
14 Stryker Medical Division of Stryker Corporation II Aug-06-2021
15 Stryker Medical Division of Stryker Corporation II Nov-09-2018
16 Umano Medical, Inc. II May-26-2022
17 Umano Medical, Inc. II Jun-02-2020
18 Vitalgo Inc. II Aug-09-2018
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