TPLC - Total Product Life Cycle

• Device: patient bed with canopy/restraints
• Regulation Description: Protective restraint.
• 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
2020	6	6
2021	5	5
2022	28	28
2023	7	7
2024	31	31
2025	34	34

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	44	44
Mechanical Problem	22	22
Break	13	13
Material Split, Cut or Torn	8	8
Insufficient Information	8	8
Use of Device Problem	6	6
Fail-Safe Did Not Operate	5	5
Fail-Safe Problem	4	4
Component Missing	4	4
Improper or Incorrect Procedure or Method	4	4
Material Integrity Problem	2	2
Patient Device Interaction Problem	2	2
Material Fragmentation	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Deformation Due to Compressive Stress	2	2
Material Frayed	1	1
Crack	1	1
Material Puncture/Hole	1	1
Patient-Device Incompatibility	1	1
Positioning Failure	1	1
Material Perforation	1	1
Material Deformation	1	1
Device Handling Problem	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Nonstandard Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	79	79
Insufficient Information	10	10
Physical Entrapment	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
No Consequences Or Impact To Patient	5	5
Abrasion	2	2
Respiratory Arrest	1	1
Unspecified Musculoskeletal problem	1	1
Fall	1	1
Limb Fracture	1	1
Airway Obstruction	1	1
Bruise/Contusion	1	1

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