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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessory to continuous ventilator (respirator)
Regulation Description Continuous ventilator.
Product CodeMOD
Regulation Number 868.5895
Device Class 2


Premarket Reviews
ManufacturerDecision
BREAS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Disconnection 1 1
Crack 1 1
Failure to Deliver 1 1
Connection Problem 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 1 1
Wound Dehiscence 1 1
No Known Impact Or Consequence To Patient 1 1
Fall 1 1
Bradycardia 1 1
Low Oxygen Saturation 1 1

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