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	94	94
No Audible Alarm	26	26
Material Split, Cut or Torn	25	25
Activation Problem	15	15
Collapse	9	9
Material Frayed	6	6
Mechanical Problem	5	5
Appropriate Term/Code Not Available	5	5
Material Integrity Problem	4	4
Patient Device Interaction Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Insufficient Information	3	3
Defective Alarm	3	3
Structural Problem	2	2
Material Separation	2	2
Electrical /Electronic Property Problem	2	2
Mechanical Jam	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
Misassembled	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
Protective Measures 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	178	178
Fall	12	12
Insufficient Information	6	6
Bruise/Contusion	5	5
Laceration(s)	3	3
Strangulation	2	2
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hip Fracture	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Hematoma	1	1
Crushing Injury	1	1
Pain	1	1
Eye Injury	1	1
Limb Fracture	1	1
Swelling/ Edema	1	1
Pressure Sores	1	1
Loss of consciousness	1	1

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