TPLC - Total Product Life Cycle

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Device	bed, manual
Regulation Description	Manual adjustable hospital bed.
Product Code	FNJ
Regulation Number	880.5120
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	62	62
No Audible Alarm	24	24
Material Split, Cut or Torn	17	17
Activation Problem	12	12
Adverse Event Without Identified Device or Use Problem	6	6
Material Frayed	5	5
Appropriate Term/Code Not Available	5	5
Mechanical Problem	4	4
Collapse	4	4
Patient Device Interaction Problem	3	3
Insufficient Information	2	2
Defective Alarm	2	2
Activation, Positioning or Separation Problem	1	1
Entrapment of Device	1	1
Physical Resistance/Sticking	1	1
Device Alarm System	1	1
Device Damaged Prior to Use	1	1
Material Integrity Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Twisted/Bent	1	1
Sharp Edges	1	1
Material Deformation	1	1
Detachment of Device or Device Component	1	1
No Apparent Adverse Event	1	1
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	127	127
Fall	10	10
Laceration(s)	4	4
Bruise/Contusion	4	4
Insufficient Information	3	3
Bone Fracture(s)	2	2
Strangulation	2	2
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hip Fracture	1	1
Head Injury	1	1
Hematoma	1	1
Crushing Injury	1	1
Pain	1	1
Eye Injury	1	1
Limb Fracture	1	1
Loss of consciousness	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Oakworks Inc	II	Jun-06-2022