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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device infant supine sleep system
Definition An infant supine sleep system is a device intended to facilitate a supine position during sleep for use in infants that are not yet able to roll over consistently. Infants placed in a supine sleep position are at lower risk of sudden infant death syndrome (SIDS) or sudden unexpected infant death (SUID).
Product CodeQTG
Regulation Number 880.5690
Device Class 2


Premarket Reviews
ManufacturerDecision
HAPPIEST BABY, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2024 3 3
2025 2 2
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
No Apparent Adverse Event 2 2
Product Quality Problem 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Protective Measures Problem 1 1
Unexpected Shutdown 1 1
Premature Separation 1 1
Application Network Problem 1 1
Application Program Version or Upgrade Problem 1 1
Communication or Transmission Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
Insufficient Information 2 2
Unspecified Respiratory Problem 1 1

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