TPLC - Total Product Life Cycle

show TPLC since

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	93	93
No Audible Alarm	26	26
Material Split, Cut or Torn	25	25
Activation Problem	15	15
Collapse	7	7
Material Frayed	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Mechanical Problem	5	5
Appropriate Term/Code Not Available	5	5
Patient Device Interaction Problem	3	3
Defective Alarm	3	3
Insufficient Information	2	2
Material Integrity Problem	2	2
Loose or Intermittent Connection	2	2
Activation, Positioning or Separation Problem	1	1
Break	1	1
Entrapment of Device	1	1
Physical Resistance/Sticking	1	1
Device Alarm System	1	1
Device Damaged Prior to Use	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
Device Dislodged or Dislocated	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	175	175
Fall	12	12
Insufficient Information	5	5
Laceration(s)	5	5
Bruise/Contusion	5	5
Bone Fracture(s)	2	2
Strangulation	2	2
Pain	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Infection	1	1
Hip Fracture	1	1
Hematoma	1	1
Head Injury	1	1
Crushing Injury	1	1
Eye Injury	1	1
Limb Fracture	1	1
Swelling/ Edema	1	1
Loss of consciousness	1	1

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