Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 1646 2527

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 971 1158
Unintended Movement 793 896
Device Alarm System 589 589
Incorrect Measurement 529 3606
Electrical /Electronic Property Problem 487 2589
Mechanical Problem 459 1871
Material Split, Cut or Torn 438 438
Defective Alarm 371 371
Detachment of Device or Device Component 334 334
Unintended System Motion 319 957
Device Slipped 234 245
Use of Device Problem 233 287
Break 188 188
Device Fell 148 229
Sharp Edges 143 234
Adverse Event Without Identified Device or Use Problem 133 133
Intermittent Loss of Power 115 752
Positioning Failure 93 141
Activation Problem 82 82
Appropriate Term/Code Not Available 82 82
Unclear Information 71 71
Self-Activation or Keying 70 70
Sparking 69 69
Insufficient Information 67 67
Defective Component 61 61
Collapse 44 44
Loose or Intermittent Connection 41 41
Component Missing 40 40
Material Frayed 39 39
Fire 36 36
No Apparent Adverse Event 36 38
Positioning Problem 33 41
Circuit Failure 30 30
Device Operates Differently Than Expected 30 30
Communication or Transmission Problem 28 28
Failure to Zero 25 25
Improper or Incorrect Procedure or Method 24 24
Smoking 24 23
Defective Device 23 23
Material Twisted/Bent 21 21
Pressure Problem 20 20
Electrical Shorting 19 19
Intermittent Continuity 19 19
Electromagnetic Interference 18 18
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Patient Device Interaction Problem 18 18
Alarm Not Visible 17 23
Physical Resistance/Sticking 15 15
Protective Measures Problem 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
Delayed Alarm 5 5
Detachment Of Device Component 4 4
Crack 4 4
Fracture 4 4
Device Emits Odor 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
Wireless Communication Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3423 7408
No Patient Involvement 2102 6568
No Known Impact Or Consequence To Patient 572 627
No Consequences Or Impact To Patient 489 762
Insufficient Information 355 355
Fall 334 406
Pressure Sores 135 135
Bone Fracture(s) 59 59
Laceration(s) 59 59
Pain 43 116
Death 40 40
Injury 33 33
Hip Fracture 28 28
Bruise/Contusion 26 28
Physical Entrapment 24 24
Abrasion 19 23
Unspecified Tissue Injury 18 18
Electric Shock 17 17
Head Injury 14 14
Hematoma 10 10
Burn(s) 8 8
Hemorrhage/Bleeding 5 5
Hemorrhage, Subdural 5 5
Skin Tears 5 5
Shock 5 28
Skull Fracture 5 5
No Information 5 5
Limb Fracture 5 5
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
Discomfort 3 3
Decreased Respiratory Rate 3 3
Fracture, Arm 3 3
Brain Injury 3 3
Unintended Extubation 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Blister 2 2
Syncope/Fainting 2 2
Blood Loss 2 2
Confusion/ Disorientation 2 2
Patient Problem/Medical Problem 2 2
Disc Impingement 2 2
Strangulation 2 2
Swelling 2 2
Skin Discoloration 2 2
Neck Pain 2 2
Neurological Deficit/Dysfunction 2 2
Choking 2 2
Loss of consciousness 2 2
Tooth Fracture 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
Adult Respiratory Distress Syndrome 1 1
Aspiration/Inhalation 1 1
Bacterial Infection 1 1
Exsanguination 1 1
Ecchymosis 1 1
Emotional Changes 1 1
Spinal Cord Injury 1 1
Ventilator Dependent 1 1
Laceration(s) of Esophagus 1 1
Extubate 1 1
Numbness 1 1
Post Traumatic Wound Infection 1 1
Suture Abrasion 1 1
Sleep Dysfunction 1 1
Ambulation Difficulties 1 1
Respiratory Distress 1 1
Tissue Damage 1 1
Ulcer 1 1
Anaphylactoid 1 1
Deformity/ Disfigurement 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
Partial thickness (Second Degree) Burn 1 1
Localized Skin Lesion 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 Aug-06-2021
14 Stryker Medical Division of Stryker Corporation II Nov-09-2018
15 Umano Medical, Inc. II May-26-2022
16 Umano Medical, Inc. II Jun-02-2020
17 Vitalgo Inc. II Aug-09-2018
-
-