TPLC - Total Product Life Cycle

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Device	bed, flotation therapy, powered
Regulation Description	Powered flotation therapy bed.
Product Code	IOQ
Regulation Number	890.5170
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	197	197
Unintended Movement	88	91
Positioning Failure	45	45
Activation Problem	42	42
Use of Device Problem	32	32
Pressure Problem	21	21
Inflation Problem	20	20
Appropriate Device Problem Term/Code Not Available	14	14
Insufficient Device Problem Information	13	13
Sparking	12	12
Mechanical Problem	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Material Too Soft/Flexible	8	9
No Audible Alarm	8	8
Component or Accessory Incompatibility	7	7
Electrical /Electronic Property Problem	6	6
Material Frayed	5	5
Defective Alarm	5	5
Material Deformation	4	4
Scratched Material	4	4
Collapse	3	3
Patient Device Interaction Problem	3	3
Use of Incorrect Control/Treatment Settings	2	2
Sharp Edges	2	2
Gas/Air Leak	2	2
Flare or Flash	2	2
Positioning Problem	2	2
Unintended Deflation	2	4
Fire	2	2
Break	2	2
Decrease in Pressure	1	1
Degraded	1	1
Deflation Problem	1	1
Misassembled	1	1
No Audible Prompt/Feedback	1	1
Smoking	1	1
Material Protrusion/Extrusion	1	1
Activation Failure	1	1
Device Alarm System	1	1
Power Problem	1	1
Grounding Malfunction	1	1
Connection Problem	1	1
Naturally Worn	1	1
Complete Loss of Power	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	670	675
Insufficient Information	61	61
Pressure Sore/Ulcer	53	53
Fall	6	6
Unspecified Tissue Injury	6	6
Erythema	5	5
Ulcer	4	4
Blister	3	3
Skin Infection	2	2
Electric Shock	2	2
Laceration(s)	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Cyanosis	1	1
Damage to Ligament(s)	1	1
Bone Fracture(s)	1	1
Inflammation	1	1
Cardiac Arrest	1	1
Needle Stick/Puncture	1	1
Depression	1	1
Pain	1	1
Scar Tissue	1	1
Shock	1	1
Immunodeficiency	1	1
Low Oxygen Saturation	1	1
Device Embedded In Tissue or Plaque	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Mar-26-2025
2	Baxter Healthcare Corporation	II	Jun-14-2024
3	Baxter Healthcare Corporation	II	Mar-29-2024
4	Baxter Healthcare Corporation	II	Nov-02-2023
5	Baxter Healthcare Corporation	II	May-01-2023
6	Baxter Healthcare Corporation	II	Jul-20-2022
7	Baxter Healthcare Corporation	II	Mar-23-2022