Problem Description
Blockage within device or device component
Coagulation in device or device ingredient
Application interface becomes non-functional or program exits abnormally
Deflation due to damage from surgical instrument
Dose calculation error due to software problem
Energy output to patient tissue incorrect
Entrapment of device or device component
Error or warning message, failure to produce
False reading from device non-compliance
Hydrogen peroxide sterilization, explosion during
Injector system failure, overinfusion of
Injector system failure, underinfusion of
Inadequate instructions for healthcare professional
Intra-cavity procedure, fiberoptic break or fragmentation during
Device abrasion from instrument or another object
Motor drive unit (MDU) stalled or jammed
Overheating of device or device component
Parameter calculation error due to software problem
Power calculation error due to software problem
Precipitate in device or device ingredient
User used incorrect product for intended use
Therapy delivered to incorrect body area
Rate modulated pacing sensor, failure of
Device, or device fragments remain in patient
Rupture due to damage from surgical instrument
Stuck in inspiratory or expiratory phase
Alarm system, failure of message-battery status
Alarm system, failure of message-check electrode
Alarm system, failure of message-leads off
Alarm system, failure of message-service
Tears, rips, holes in device, device material
Automatic injection system, failure to infuse
IUD (intrauterine contraceptive device), removal of
Improper or incorrect procedure or method
Other (for use when an appropriate device code cannot be identified)
Unknown (for use when the device problem is not known)
Water softener regeneration cycle, mistiming of
Device contamination with blood or blood product
Alarm, failure of high inspiratory pressure
Alarm, failure of low inspiratory pressure
Leaflet disruption due to suture abrasion
Device or device fragments location unknown
Lead tip breakage at implant, fragments remain in ventricle
Lens (IOL), defective, problem not specified
Implant Mobility NOS (Not otherwise specified)
Cannula Guide, Needle Insertion Difficult
Immediate/early load (prior to four - six month traditional time period)
Application program version or upgrade problem
Disinfection or Sterilization Issue at User Location
Contamination of device ingredient or reagent
Detachment of device or device component
Device Contamination with biological material
Device disinfection or sterilization issue
Device misassembled during manufacturing or shipping
Device operates differently than expected
Device or device component damaged by another device
Difficult to open or remove packaging material
Inadequate instructions for non-healthcare professional
Item contaminated during manufacturing or shipping
Lack of maintenance documentation or guidelines
Maintenance does not comply to manufacturers recommendations
Manufacturing or shipping issue associated with device
Operating system version or upgrade problem
Sediment, precipitate or deposit in device or device ingredient
Therapeutic or diagnostic output failure