TPLC - Total Product Life Cycle

• Device: disinfector, medical devices
• Product Code: MEC
• Regulation Number: 880.6992
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2019	78	78
2020	80	80
2021	92	92
2022	85	85
2023	79	79
2024	40	40

Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	53	53
Leak/Splash	49	49
Adverse Event Without Identified Device or Use Problem	40	40
Fire	35	35
Device Fell	35	35
Fluid/Blood Leak	34	34
Insufficient Information	24	24
Mechanical Jam	22	22
Device Handling Problem	21	21
Smoking	20	20
Use of Device Problem	18	18
Improper or Incorrect Procedure or Method	16	16
Device Dislodged or Dislocated	12	12
Contamination /Decontamination Problem	11	11
Problem with Software Installation	11	11
Failure to Disinfect	11	11
Chemical Problem	10	10
Sparking	8	8
Sharp Edges	8	8
Break	7	7
Overheating of Device	7	7
Device Emits Odor	6	6
Installation-Related Problem	6	6
Unintended Electrical Shock	6	6
No Apparent Adverse Event	5	5
Unintended System Motion	5	5
Failure to Pump	5	5
Failure to Clean Adequately	4	4
Failure to Align	3	3
Mechanical Problem	3	3
Corroded	3	3
Crack	3	3
Pumping Problem	3	3
No Flow	2	2
Material Split, Cut or Torn	2	2
Difficult to Open or Close	2	2
Computer Software Problem	2	2
Fracture	2	2
Misassembled	2	2
Residue After Decontamination	2	2
Misassembled During Installation	2	2
Suction Failure	2	2
Complete Loss of Power	1	1
Misassembly During Maintenance/Repair	1	1
Inadequate or Insufficient Training	1	1
Fumes or Vapors	1	1
Defective Device	1	1
Device Tipped Over	1	1
Device Displays Incorrect Message	1	1
Difficult to Remove	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Insufficient Flow or Under Infusion	1	1
Defective Component	1	1
Grounding Malfunction	1	1
Flaked	1	1
Melted	1	1
Device Alarm System	1	1
Circuit Failure	1	1
Device Reprocessing Problem	1	1
Electrical /Electronic Property Problem	1	1
Filling Problem	1	1
Component or Accessory Incompatibility	1	1
Failure to Shut Off	1	1
Inadequate User Interface	1	1
Infusion or Flow Problem	1	1
Application Program Problem	1	1
Deformation Due to Compressive Stress	1	1
Calibration Problem	1	1
Device Ingredient or Reagent Problem	1	1
Device Sensing Problem	1	1
Difficult to Advance	1	1
Physical Resistance/Sticking	1	1
Positioning Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Twisted/Bent	1	1
Temperature Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unintended Movement	1	1
Device Difficult to Maintain	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	174	174
No Known Impact Or Consequence To Patient	54	54
No Consequences Or Impact To Patient	49	49
Injury	34	34
Insufficient Information	26	26
Laceration(s)	26	26
Bruise/Contusion	20	20
Fall	14	14
Abrasion	10	10
Pain	10	10
Skin Tears	8	8
Bone Fracture(s)	6	6
Muscle/Tendon Damage	5	5
Unspecified Tissue Injury	4	4
Unspecified Musculoskeletal problem	3	3
Burn, Thermal	3	3
No Patient Involvement	3	3
Superficial (First Degree) Burn	3	3
Electric Shock	2	2
Burn(s)	2	2
Loss of Range of Motion	2	2
Skin Irritation	2	2
Irritation	2	2
Damage to Ligament(s)	1	1
Concussion	1	1
Contusion	1	1
Crushing Injury	1	1
Ecchymosis	1	1
Hematoma	1	1
Inflammation	1	1
Patient Problem/Medical Problem	1	1
Partial thickness (Second Degree) Burn	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Getinge Group Logistics America, LLC	II	Feb-16-2021
2	Getinge Usa Sales Inc	II	Jun-08-2022
3	Getinge Usa Sales Inc	II	May-13-2022
4	Maquet Cardiovascular Us Sales, Llc	III	Feb-27-2020
5	Maquet Cardiovascular Us Sales, Llc	II	Feb-18-2020
6	Maquet Cardiovascular Us Sales, Llc	II	Jun-13-2019
7	Steris Corporation	II	May-17-2023
8	Steris Corporation	II	Jun-09-2022
9	Steris Corporation	II	Jan-15-2021
10	Steris Corporation	II	Mar-09-2019