TPLC - Total Product Life Cycle

• Device: patient bed with canopy/restraints
• Definition: Enclosed bed canopy system used as passive restraint.
• Product Code: OYS
• Regulation Number: 880.6760
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	16	16
2020	6	6
2021	5	5
2022	28	28
2023	7	7
2024	4	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	23	23
Mechanical Problem	21	21
Break	12	12
Product Quality Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Material Integrity Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Deformation Due to Compressive Stress	2	2
Improper or Incorrect Procedure or Method	2	2
Appropriate Term/Code Not Available	2	2
Patient Device Interaction Problem	2	2
Material Split, Cut or Torn	2	2
Misassembled During Installation	1	1
Device Handling Problem	1	1
Material Perforation	1	1
Defective Component	1	1
Dent in Material	1	1
Patient-Device Incompatibility	1	1
Crack	1	1
Positioning Failure	1	1
Material Frayed	1	1
Nonstandard Device	1	1
Material Puncture/Hole	1	1
No Apparent Adverse Event	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	38	38
No Consequences Or Impact To Patient	19	19
Insufficient Information	2	2
Physical Entrapment	1	1
Not Applicable	1	1
Respiratory Arrest	1	1
Limb Fracture	1	1
Abrasion	1	1
Airway Obstruction	1	1
Fall	1	1
Bone Fracture(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Sensory Medical Inc	I	Apr-14-2022