About: Medical Device Problem Codes FDA CDRH

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Attributes	Values
rdf:type	Class
rdfs:label	Medical Device Problem Codes FDA CDRH
rdfs:subClassOf	FDA Center For Devices and Radiological Health Terminology
Semantic_Type	Intellectual Product
Preferred_Name	Medical Device Problem Codes FDA CDRH
UMLS_CUI	C1708964
Contributing_Source	FDA
Legacy_Concept_Name	Medical_Device_Problem_Codes_FDA_CDRH
FULL_SYN	Medical Device Problem Terminology FDA CDRHSYNCI Medical Device Problem Terminology FDA Center for Devices and Radiological HealthSYNCI Medical Device Problem Codes FDA CDRHPTNCI
DEFINITION	Terminology used for defining mode of medical device failure or malfunction in individual case reports for voluntary and mandatory reporting of adverse reactions or adverse events during both pre and post approval periods of medical device development and usage.NCI
code	C54451
is Concept_In_Subset of	Wireless Communication Issue Associated with Medical Device Not Applicable Volume Accuracy Issue Associated with Medical Device Unstable Medical Device Problem Unsealed Medical Device Packaging Unraveled Medical Device Material Unintended System Motion Medical Device Problem Unintended Film Cartridge Ejection Medical Device Problem Unintended Energization of Medical Device Unintended Collision Medical Device Problem Unexpected Therapeutic Result Therapeutic or Diagnostic Output Failure Associated with Medical Device Telemetry Discrepancy Medical Device Problem Tear, Rip or Hole in Medical Device Packaging Tear in Medical Device Material Strikethrough Medical Device Problem Sticking Medical Device Problem Spark Associated with Medical Device Solder Joint Failure Medical Device Problem Short Fill Medical Device Problem Shielding Failure Medical Device Problem Self-Activation of Medical Device Rigid or Stiff Medical Device Material Restricted Flow Rate Medical Device Problem Residue after Decontamination Medical Device Problem Rejection Due to Device-Patient Incompatibility Reflux within Device Medical Device Problem Radiation Delivered to Incorrect Body Area Medical Device Problem Pumping Stopped Medical Device Problem Plunge Medical Device Problem Pitted Medical Device Material Particulates in Medical Device Environment Excess Flow or Overinfusion Medical Device Problem Nonstandard Medical Device or Device Component No Voice Prompts Medical Device Problem Naturally Worn Medical Device Material Molten Medical Device Material Moisture or Humidity Problem Associated with Medical Device Moisture Damage to Medical Device Misfocusing Medical Device Problem Misfire Medical Device Problem Misconnection Medical Device Problem Miscalculation of Power Due to Software Problem Metal Shedding Debris in Medical Device Patient-Device Incompatibility Medical Device Problem Medical Device Stops Intermittently Medical Device Shelf Life Exceeded Medical Device or Device Component Failure to Unfold or Unwrap Medical Device or Device Component Damaged by another Device Medical Device Misassembled by Users Medical Device Material Split Medical Device Material Separation Medical Device Material Rupture Medical Device Material Puncture Medical Device Material Fragmentation Medical Device Material Crack Medical Device Burst Medical Device Markings Issue Medical Device Maintenance Does not Comply to Manufacturers Recommendations Medical Device Inoperable Medical Device Ingredient pH High Medical Device Filtration Process Inadequate Medical Device Filtration Issue Medical Device Failure to Zero Medical Device Failure to Shut Off Medical Device Failure to Self-Test Medical Device Failure to Run on Portable Mode Medical Device Failure to Reset Medical Device Failure to Capture Medical Device Failure to Auto Stop Medical Device Expiration Date Error Medical Device Energy Spectrum Incorrect Medical Device Energy Output to Patient Tissue Incorrect Medical Device Emits Smoke Medical Device Emits Odor Medical Device Difficult to Prepare Medical Device Difficult to Open or Close Medical Device Delivered As Unsterile Product Medical Device Damage Prior to Use Medical Device Contamination with Blood or Blood Product Medical Device Contaminated during Manufacturing or Shipping Medical Device Component Missing Medical Device Component Incompatibility Medical Device Component Defective Medical Device Clogged Medical Device Power Source Issue Medical Device Calibration Issue

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