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	80	80
Insufficient Information	28	28
Break	27	27
Moisture Damage	21	21
Use of Device Problem	17	17
Difficult to Open or Close	17	17
Device Operates Differently Than Expected	15	15
Electrical /Electronic Property Problem	11	11
Device Handling Problem	9	9
Device Inoperable	9	9
Contamination	8	8
Defective Component	8	8
Device Displays Incorrect Message	8	8
Fluid/Blood Leak	7	7
Mechanical Problem	7	7
Material Discolored	6	6
Patient Device Interaction Problem	6	6
Improper or Incorrect Procedure or Method	6	6
Unintended System Motion	6	6
Sticking	5	5
Unintended Movement	5	5
Torn Material	4	4
No Apparent Adverse Event	4	4
Patient-Device Incompatibility	4	4
No Display/Image	4	4
Positioning Problem	4	4
Cut In Material	4	4
Deflation Problem	4	4
Human Factors Issue	4	4
Device Slipped	4	4
Detachment Of Device Component	4	4
Detachment of Device or Device Component	3	3
Material Too Soft/Flexible	3	3
Difficult To Position	3	3
Material Integrity Problem	3	3
Bent	3	3
Device Issue	3	3
Inflation Problem	3	3
Sharp Edges	3	3
Product Quality Problem	2	2
Human-Device Interface Problem	2	2
Application Interface Becomes Non-Functional Or Program Exits Abnormally	2	2
Misconnection	2	2
Loose or Intermittent Connection	2	2
Mechanical Jam	2	2
Difficult or Delayed Positioning	2	2
Hole In Material	2	2
Scratched Material	2	2
Defective Device	2	2
Material Puncture/Hole	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	79	79
Pressure Sores	70	70
No Consequences Or Impact To Patient	44	44
Injury	20	20
Death	17	17
Tissue Damage	12	12
No Clinical Signs, Symptoms or Conditions	12	12
Fall	11	11
Tissue Breakdown	10	10
Low Oxygen Saturation	9	9
Pain	9	9
No Information	8	8
Insufficient Information	4	4
Skin Tears	3	3
Cardiac Arrest	3	3
Skin Erosion	3	3
Hyperemia	2	2
Tachycardia	2	2
Physical Entrapment	2	2
Cardiopulmonary Arrest	2	2
No Patient Involvement	2	2
Loss Of Pulse	2	2
No Code Available	2	2
Hypoventilation	2	2
Complaint, Ill-Defined	2	2
Foreign Body In Patient	1	1
Skin Discoloration	1	1
Dyspnea	1	1
Contusion	1	1
Laceration(s)	1	1
Scar Tissue	1	1
Bradycardia	1	1
Skin Disorders	1	1
Bone Fracture(s)	1	1
Unspecified Tissue Injury	1	1
Necrosis	1	1
Loss of Vision	1	1
Failure of Implant	1	1
Electric Shock	1	1
Bacterial Infection	1	1
Extubate	1	1
Unintended Extubation	1	1
Patient Problem/Medical Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arjo Hospital Equipment AB	II	Feb-27-2015
2	ArjoHuntleigh Inc.	II	Feb-04-2014
3	Arjohuntleigh Magog	II	Feb-05-2019
4	KCI USA, Inc.	II	May-10-2011
5	KCI USA, Inc.	II	Dec-13-2010
6	Kinsman Enterprises Inc	II	Oct-21-2021
7	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021