TPLC - Total Product Life Cycle

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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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	78	78
Mechanical Problem	19	19
Break	18	18
Material Split, Cut or Torn	17	17
Insufficient Information	12	12
Fail-Safe Did Not Operate	12	12
Use of Device Problem	7	7
Component Missing	6	6
Fail-Safe Problem	5	5
Improper or Incorrect Procedure or Method	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Deformation Due to Compressive Stress	2	2
Material Fragmentation	2	2
Material Integrity Problem	2	2
Device Handling Problem	2	2
Patient Device Interaction Problem	2	2
Defective Component	1	1
Separation Failure	1	1
Patient-Device Incompatibility	1	1
Detachment of Device or Device Component	1	1
Crack	1	1
Positioning Failure	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Deformation	1	1
No Apparent Adverse Event	1	1
Appropriate Term/Code Not Available	1	1
Nonstandard Device	1	1
Material Puncture/Hole	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	114	114
Physical Entrapment	16	16
Insufficient Information	14	14
Abrasion	11	11
Bruise/Contusion	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Laceration(s)	4	4
Bone Fracture(s)	3	3
Fall	3	3
Joint Dislocation	1	1
Respiratory Arrest	1	1
Unspecified Musculoskeletal problem	1	1
Limb Fracture	1	1
Convulsion/Seizure	1	1
Skin Tears	1	1
Airway Obstruction	1	1

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