TPLC - Total Product Life Cycle

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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
Break	11	11
Electrical /Electronic Property Problem	11	11
Device Handling Problem	9	9
Device Inoperable	8	8
Defective Component	8	8
Device Operates Differently Than Expected	7	7
Mechanical Problem	6	6
Patient Device Interaction Problem	6	6
Unintended Movement	5	5
Unintended System Motion	5	5
No Apparent Adverse Event	4	4
No Display/Image	4	4
Human Factors Issue	4	4
Positioning Problem	4	4
Detachment Of Device Component	4	4
Patient-Device Incompatibility	4	4
Device Displays Incorrect Message	4	4
Device Slipped	3	3
Cut In Material	3	3
Detachment of Device or Device Component	3	3
Difficult To Position	3	3
Sharp Edges	3	3
Material Too Soft/Flexible	3	3
Device Issue	3	3
Product Quality Problem	2	2
Sticking	2	2
Inflation Problem	2	2
Difficult or Delayed Positioning	2	2
Defective Device	2	2
Material Integrity Problem	2	2
Device Alarm System	2	2
Mechanical Jam	2	2
Loose or Intermittent Connection	2	2
Human-Device Interface Problem	2	2
Low Audible Alarm	2	2
Device Dislodged or Dislocated	2	2
Deflation Problem	2	2
Scratched Material	2	2
Improper or Incorrect Procedure or Method	1	1
Loss of Power	1	1
Crack	1	1
Intermittent Energy Output	1	1
No Device Output	1	1
Noise, Audible	1	1
Separation Failure	1	1
Unclear Information	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