Protective measures problem

Definition

Problem associated with any deviations from the documented specifications of the device that relate to the implemented and inherited design features specific to devices used for reducing risks to patient or caregiver or maintaining risks within specified levels.

7 subordinate codes

• XE98HDevice alarm system
• XE78DFail-safe problem
• XE3V3Failure of device to self-test
• XE16YFailure to auto stop
• XE4KEReset problem
• XE1H0Premature indicator activation
• XE4PSShielding failure

Also indexed as

Nearby in Aspects of incidents related to devices

• XE4HKPatient device interaction problem
• XE7Q8Manufacturing, packaging or shipping problem
• XE52XChemical problem
• XE4LPMaterial integrity problem
• XE2GFMechanical problem
• XE941Optical problem
• XE28YOutput problem
• XE16CElectrical or electronic property problem