Good Faith Safety Concern Threshold Invoked By Engineer A Without Confirmed Incidents
P · Principle
Individual
http://proethica.org/ontology/case/150#Good_Faith_Safety_Concern_Threshold_Invoked_By_Engineer_A_Without_Confirmed_Incidents
Properties
Instance of
GoodFaithSafetyConcernThresholdforExternalReporting
http://proethica.org/ontology/intermediate#GoodFaithSafetyConcernThresholdforExternalReporting
Applied to
Absence of confirmed incidents as potential barrier to reporting
Infant respirator potential overpressure defect
Balancing with
Contextual Calibration of Public Safety Reporting Obligation
Graduated Internal Escalation Before External Reporting Obligation
Concrete expression
Engineer A's professional judgment that the relief valve may have been incorrectly placed — even without any reported incidents — constitutes a sufficient good faith basis to justify and ultimately require reporting to a federal regulatory agency
Confidence
0.95
Importance
high
Interpretation
The absence of confirmed incidents does not negate Engineer A's reporting obligation; his professional judgment that the design could cause harm to infants under certain circumstances is sufficient to trigger the good faith reporting threshold
Invoked by
Engineer A Medical Device Safety Review Engineer
Tension resolution
Good faith professional belief in a genuine safety risk is sufficient to trigger reporting obligation even without confirmed incidents; the threshold is professional judgment, not certainty
Source Evidence
Source text
although no incidents have been reported
Text references
Engineer A indicates that if prompt measures are not taken to correct the problem, he will be compelled to report the matter to an appropriate federal regulatory agency
although no incidents have been reported
an infant could potentially experience dangerously high pressure levels—although no incidents have been reported
TTL
@prefix case150: <http://proethica.org/ontology/case/150#> .
@prefix owl: <http://www.w3.org/2002/07/owl#> .
@prefix proeth: <http://proethica.org/ontology/intermediate#> .
@prefix prov: <http://www.w3.org/ns/prov#> .
@prefix rdfs: <http://www.w3.org/2000/01/rdf-schema#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .
case150:Good_Faith_Safety_Concern_Threshold_Invoked_By_Engineer_A_Without_Confirmed_Incidents a proeth:GoodFaithSafetyConcernThresholdforExternalReporting,
owl:NamedIndividual ;
rdfs:label "Good Faith Safety Concern Threshold Invoked By Engineer A Without Confirmed Incidents" ;
proeth:appliedto "Absence of confirmed incidents as potential barrier to reporting",
"Infant respirator potential overpressure defect" ;
proeth:balancingwith "Contextual Calibration of Public Safety Reporting Obligation",
"Graduated Internal Escalation Before External Reporting Obligation" ;
proeth:conceptCategory "Principle" ;
proeth:concreteexpression "Engineer A's professional judgment that the relief valve may have been incorrectly placed — even without any reported incidents — constitutes a sufficient good faith basis to justify and ultimately require reporting to a federal regulatory agency" ;
proeth:confidence "0.95" ;
proeth:discoveredincase "150" ;
proeth:discoveredinpass "2" ;
proeth:discoveredinsection "facts" ;
proeth:firstdiscoveredat "2026-02-28T14:34:13.990593+00:00" ;
proeth:firstdiscoveredincase "150" ;
proeth:generatedattime "2026-02-28T14:34:13.990593+00:00" ;
proeth:importance "high" ;
proeth:interpretation "The absence of confirmed incidents does not negate Engineer A's reporting obligation; his professional judgment that the design could cause harm to infants under certain circumstances is sufficient to trigger the good faith reporting threshold" ;
proeth:invokedby "Engineer A Medical Device Safety Review Engineer" ;
proeth:principleclass "Good Faith Safety Concern Threshold for External Reporting" ;
proeth:sourcetext "although no incidents have been reported" ;
proeth:tensionresolution "Good faith professional belief in a genuine safety risk is sufficient to trigger reporting obligation even without confirmed incidents; the threshold is professional judgment, not certainty" ;
proeth:textreferences "Engineer A indicates that if prompt measures are not taken to correct the problem, he will be compelled to report the matter to an appropriate federal regulatory agency",
"although no incidents have been reported",
"an infant could potentially experience dangerously high pressure levels—although no incidents have been reported" ;
proeth:wasattributedto "Case 150 Extraction" ;
prov:generatedAtTime "2026-02-28T14:52:22.174678"^^xsd:dateTime ;
prov:wasGeneratedBy "ProEthica Case 150 Extraction" .
Metadata
Extraction details
Discovered in case
150
Discovered in pass
2
Discovered in section
facts
First discovered
2026-02-28T14:34:13.990593+00:00
First case
150
Generated
2026-02-28T14:34:13.990593+00:00
Attributed to
Case 150 Extraction
Generated
2026-02-28T14:52:22.174678
Generated by
ProEthica Case 150 Extraction