TPLC - Total Product Life Cycle

• Device: bed, pediatric open hospital
• Regulation Description: Pediatric medical crib.
• Product Code: FMS
• Regulation Number: 880.5140
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2020	28	139
2021	28	91
2022	22	91
2023	29	131
2024	30	116
2025	26	114
2026	3	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Positioning Failure	65	459
Device Fell	42	118
Incorrect Measurement	23	60
Mechanical Jam	8	19
Patient Device Interaction Problem	5	6
Mechanical Problem	4	4
Break	3	3
Fluid/Blood Leak	3	6
Device Slipped	2	2
Sharp Edges	2	2
Device Dislodged or Dislocated	2	4
Activation, Positioning or Separation Problem	1	1
Entrapment of Device	1	1
Collapse	1	1
Defective Component	1	2
Positioning Problem	1	2
Difficult or Delayed Positioning	1	1
Product Quality Problem	1	1
Detachment of Device or Device Component	1	1
Protective Measures Problem	1	1
Unintended System Motion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	138	577
No Patient Involvement	16	111
Insufficient Information	6	6
Bruise/Contusion	2	2
Fall	2	16
No Consequences Or Impact To Patient	2	2
Physical Entrapment	2	3
Low Oxygen Saturation	1	1
Pain	1	2
Concussion	1	1
Cardiac Arrest	1	1
Cyanosis	1	1
Abrasion	1	2
Bradycardia	1	1
No Known Impact Or Consequence To Patient	1	1
Respiratory Arrest	1	1
Vertebral Fracture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	PediaLift LLC	II	Feb-02-2020
2	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021