Device product
IMRIS MR/X-ray head fixation device, Model HFD200
Z-0163-2020
Product summary
- Event
- Event 83278
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-0163-2020
Official wording
Reason: Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient force; the clinical staff unknowingly pinning the patient's skull with excessive force; or the clinical staff identifying the issue and not being able to continue with the procedure.
Code information: HFD Serial Number Drive Knob Serial Number 10002481 10003305 10002351 10005723 10004247 10002448
Distribution pattern: TN, NH, FL
Derived failure modes
-
Unknown
Breaking of the HFD200 Drive Knob force indicator due to over-torqueing of the drive knob beyond the maximum allowable pinning force specification may result in the clinical staff unknowingly pinning the patient's skull with insufficient force; the clinical staff unknowingly pinning the patient's skull with excessive force; or the clinical staff identifying the issue and not being able to continue with the procedure.