TPLC - Total Product Life Cycle

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Device	bariatric bed
Regulation Description	AC-powered adjustable hospital bed.
Definition	A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
Product Code	OSI
Regulation Number	880.5100
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Split, Cut or Torn	362	362
Activation Problem	73	73
Sparking	43	43
Material Frayed	25	25
Unintended Movement	20	20
Incorrect Measurement	18	66
Appropriate Term/Code Not Available	14	14
Positioning Failure	12	21
Break	11	11
Electrical /Electronic Property Problem	10	10
Mechanical Problem	9	9
No Audible Alarm	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Smoking	6	6
Inflation Problem	6	6
Fire	5	5
Insufficient Information	5	5
Device Fell	5	5
No Apparent Adverse Event	4	4
Temperature Problem	3	3
Unintended Electrical Shock	3	3
Patient Device Interaction Problem	3	6
Defective Alarm	3	3
Use of Device Problem	3	3
Material Deformation	3	3
Device Handling Problem	3	3
Disconnection	2	2
Off-Label Use	2	2
Collapse	2	2
Unintended System Motion	2	2
Detachment of Device or Device Component	2	2
Mechanical Jam	1	1
Connection Problem	1	1
Intermittent Continuity	1	1
Activation Failure	1	1
Electrical Shorting	1	1
Product Quality Problem	1	1
Failure to Pump	1	1
Calibration Problem	1	1
Sharp Edges	1	1
Structural Problem	1	1
Gas/Air Leak	1	1
Material Fragmentation	1	1
Key or Button Unresponsive/not Working	1	1
Contamination /Decontamination Problem	1	1
Positioning Problem	1	1
Defective Component	1	1
Device Alarm System	1	1
Activation, Positioning or Separation Problem	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	561	621
Insufficient Information	38	38
Fall	12	12
Pressure Sores	11	11
Electric Shock	6	6
Laceration(s)	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Unspecified Tissue Injury	5	5
Pain	3	6
Bone Fracture(s)	2	5
Discomfort	2	2
Strangulation	2	2
Dizziness	1	1
Low Oxygen Saturation	1	1
Balance Problems	1	1
Heart Failure/Congestive Heart Failure	1	1
Localized Skin Lesion	1	1
Head Injury	1	1
Abrasion	1	1
Burn(s)	1	1
Cardiac Arrest	1	1
Sepsis	1	1
Shock	1	1
Necrosis	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Medical Division of Stryker Corporation	II	Dec-11-2025