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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intra-abdominal pressure monitoring device
Definition Abdominal intracompartmental pressure monitoring using bladder pressure as a surrogate for abdominal pressure.
Product CodePHU
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
SENTINEL MEDICAL TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 34 34
2020 21 21
2021 21 21
2022 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 43 43
Leak/Splash 28 28
Disconnection 12 12
Defective Device 10 10
Fitting Problem 3 3
Difficult to Open or Close 2 2
Incorrect Measurement 2 2
Misassembled 2 2
Failure to Prime 2 2
Break 2 2
Material Separation 2 2
Unable to Obtain Readings 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Misconnection 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Inaccurate Flow Rate 1 1
Flushing Problem 1 1
Material Fragmentation 1 1
Inflation Problem 1 1
Excess Flow or Over-Infusion 1 1
Device Dislodged or Dislocated 1 1
Free or Unrestricted Flow 1 1
Improper Flow or Infusion 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Component Misassembled 1 1
Physical Resistance/Sticking 1 1
Suction Failure 1 1
Priming Problem 1 1
Incomplete or Inadequate Priming 1 1
Incomplete or Missing Packaging 1 1
High Test Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 47 47
No Known Impact Or Consequence To Patient 36 36
No Clinical Signs, Symptoms or Conditions 31 31
No Patient Involvement 8 8
No Code Available 2 2
Insufficient Information 2 2
Discomfort 1 1
Urinary Retention 1 1
Urinary Tract Infection 1 1
Burning Sensation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 C.R. Bard Inc II Mar-02-2020
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