TPLC - Total Product Life Cycle

show TPLC since

Device	bed, patient rotation, powered
Product Code	IKZ
Regulation Number	890.5225
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	78	78
Insufficient Information	22	22
Difficult to Open or Close	17	17
Use of Device Problem	16	16
Electrical /Electronic Property Problem	11	11
Break	11	11
Device Handling Problem	9	9
Defective Component	8	8
Device Inoperable	8	8
Device Operates Differently Than Expected	7	7
Patient Device Interaction Problem	6	6
Mechanical Problem	6	6
Unintended System Motion	5	5
Unintended Movement	5	5
Device Displays Incorrect Message	4	4
Positioning Problem	4	4
No Apparent Adverse Event	4	4
Human Factors Issue	4	4
Patient-Device Incompatibility	4	4
Detachment Of Device Component	4	4
No Display/Image	4	4
Device Issue	3	3
Material Too Soft/Flexible	3	3
Detachment of Device or Device Component	3	3
Difficult To Position	3	3
Sharp Edges	3	3
Device Slipped	3	3
Cut In Material	3	3
Loose or Intermittent Connection	2	2
Mechanical Jam	2	2
Human-Device Interface Problem	2	2
Device Alarm System	2	2
Device Dislodged or Dislocated	2	2
Defective Device	2	2
Sticking	2	2
Low Audible Alarm	2	2
Product Quality Problem	2	2
Inflation Problem	2	2
Material Integrity Problem	2	2
Difficult or Delayed Positioning	2	2
Scratched Material	2	2
Deflation Problem	2	2
Operating System Becomes Nonfunctional	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of Power	1	1
Pressure Problem	1	1
Sparking	1	1
Device Emits Odor	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Protrusion/Extrusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pressure Sores	65	65
No Consequences Or Impact To Patient	37	37
No Known Impact Or Consequence To Patient	29	29
Injury	20	20
No Clinical Signs, Symptoms or Conditions	12	12
Tissue Damage	12	12
Death	11	11
Pain	9	9
Fall	8	8
Low Oxygen Saturation	7	7
No Information	6	6
Tissue Breakdown	6	6
Insufficient Information	4	4
Cardiac Arrest	3	3
Skin Tears	3	3
Complaint, Ill-Defined	2	2
Hypoventilation	2	2
No Code Available	2	2
No Patient Involvement	2	2
Cardiopulmonary Arrest	2	2
Physical Entrapment	2	2
Tachycardia	2	2
Hyperemia	2	2
Patient Problem/Medical Problem	1	1
Electric Shock	1	1
Failure of Implant	1	1
Necrosis	1	1
Bone Fracture(s)	1	1
Skin Disorders	1	1
Contusion	1	1
Skin Discoloration	1	1
Foreign Body In Patient	1	1
Loss Of Pulse	1	1
Dyspnea	1	1
Laceration(s)	1	1
Scar Tissue	1	1
Bradycardia	1	1
Unspecified Tissue Injury	1	1
Extubate	1	1
Unintended Extubation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arjo Hospital Equipment AB	II	Feb-27-2015
2	Arjohuntleigh Magog	II	Feb-05-2019
3	Kinsman Enterprises Inc	II	Oct-21-2021
4	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021