TPLC - Total Product Life Cycle

show TPLC since

Device	table, surgical with orthopedic accessories, ac-powered
Regulation Description	Operating tables and accessories and operating chairs and accessories.
Product Code	JEA
Regulation Number	878.4960
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	46	46
Use of Device Problem	39	39
Insufficient Information	24	24
Adverse Event Without Identified Device or Use Problem	18	18
Device Slipped	14	14
Unexpected Shutdown	13	13
Device Fell	11	11
Unintended System Motion	10	10
Detachment of Device or Device Component	10	10
Break	7	7
Improper or Incorrect Procedure or Method	6	6
Device Dislodged or Dislocated	6	6
Positioning Problem	5	5
Positioning Failure	5	7
Mechanical Problem	4	4
Fracture	4	4
Crack	4	4
Material Separation	4	4
Device Handling Problem	4	4
Loss of or Failure to Bond	3	3
Output Problem	3	3
Electrical Shorting	3	3
Smoking	3	3
Corroded	2	2
Overheating of Device	2	2
Connection Problem	2	2
Misassembly by Users	2	2
Patient Device Interaction Problem	2	2
Patient-Device Incompatibility	2	2
Failure to Read Input Signal	2	3
Key or Button Unresponsive/not Working	1	1
Degraded	1	1
Battery Problem	1	1
Moisture Damage	1	1
Component Missing	1	1
Structural Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Use of Incorrect Control/Treatment Settings	1	1
Difficult or Delayed Positioning	1	1
Misconnection	1	1
Material Integrity Problem	1	1
Wireless Communication Problem	1	1
Collapse	1	1
Physical Resistance/Sticking	1	1
No Apparent Adverse Event	1	1
Communication or Transmission Problem	1	1
Malposition of Device	1	1
Protective Measures Problem	1	1
Intermittent Continuity	1	1
Device Tipped Over	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	105	107
Fall	49	49
Insufficient Information	31	31
No Known Impact Or Consequence To Patient	20	20
No Consequences Or Impact To Patient	5	5
Laceration(s)	5	5
Bruise/Contusion	4	4
Pressure Sores	4	4
Bone Fracture(s)	4	4
Unintended Extubation	3	3
Numbness	3	3
Injury	3	3
Abrasion	3	3
Aspiration/Inhalation	2	2
Paralysis	2	2
Burn(s)	2	2
Necrosis	2	2
Pain	2	2
Muscle/Tendon Damage	2	2
Swelling/ Edema	2	2
Skin Tears	2	2
Vertebral Fracture	2	2
Damage to Ligament(s)	2	2
Head Injury	1	1
Hematoma	1	1
Blister	1	1
Low Cardiac Output	1	1
Muscle Weakness	1	1
Cardiac Arrest	1	1
Paresthesia	1	1
Perforation	1	1
Erythema	1	1
No Information	1	1
No Patient Involvement	1	1
Nerve Damage	1	1
Skin Irritation	1	1
No Code Available	1	1
Hyperextension	1	1
Limb Fracture	1	1
Stenosis	1	1
Cardiovascular Insufficiency	1	1
Pulmonary Dysfunction	1	1
Arrhythmia	1	1
Extubate	1	1
Paraplegia	1	1
Respiratory Insufficiency	1	1
Bacterial Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Low Oxygen Saturation	1	1
Ambulation Difficulties	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Mar-21-2025
2	Baxter Healthcare Corporation	II	Oct-24-2024
3	Mizuho OSI	II	Oct-09-2020
4	Steris Corporation	II	Feb-24-2021