Device Manufacturing Deficiency Evaluation Conclusion

The device problem was traced back to the manufacture of the device as opposed to systems used to control the manufacture of the device (quality system). Examples include problems with construction or assembly. (Food and Drug Administration)

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Device Manufacture Date

The date (and time) on which the medical device is made.

Device Malfunction Code

A coded value specifying the defect or malfunction that occurred during use of the device.

Device Maintenance Review Evaluation Method

Performing a review the technical and corresponding administrative actions and records intended to retain an item in, or restore it to, a…

Device Maintenance Problem Evaluation Result

A device malfunction or problem that occurs because the device was not properly maintained according to the instructions (e.g., maintenance may be…

Device Maintenance Deficiency Evaluation Conclusion

Device problems that result from improper routine or preventative maintenance.

Device Magnetically Induced Torque Testing Evaluation Method

Testing the static magnetic field gradients on medical imaging devices for their ability to rotate objects.