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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
Break 2 2
Misassembled 2 2
Incorrect Measurement 2 2
Failure to Prime 2 2
Material Separation 2 2
Difficult to Open or Close 2 2
Incomplete or Inadequate Priming 1 1
No Display/Image 1 1
Incomplete or Missing Packaging 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 1
Suction Failure 1 1
Therapeutic or Diagnostic Output Failure 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Material Fragmentation 1 1
Unable to Obtain Readings 1 1
Improper Flow or Infusion 1 1
Inaccurate Flow Rate 1 1
Excess Flow or Over-Infusion 1 1
Inflation Problem 1 1
Misconnection 1 1
High Test Results 1 1
Free or Unrestricted Flow 1 1
Component Misassembled 1 1
Erratic or Intermittent Display 1 1
Device Dislodged or Dislocated 1 1
Flushing Problem 1 1
Priming Problem 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
Burning Sensation 1 1
Urinary Retention 1 1
Discomfort 1 1
Urinary Tract Infection 1 1

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