MalfunctionILZ
CHATTANOOGA SAUNDERS CERVICAL TRCTN DVCE
Received Oct 17, 2019 · Event occurred Sep 19, 2019
Report 9616086-2019-00071 · MDR key 9202056
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Not reported
- Discomfort
- Discomfort
Narrative
Additional Manufacturer Narrative
NO DEVICE WAS RETURNED FOR EVALUATION. IF THE DEVICE IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF PRODUCT EVALUATION.
Description of Event or Problem
IT WAS REPORTED THAT THE UNIT DOES NOT MAINTAIN PRESSURE IN THE HOLD POSITION; THERE IS A LOSS OF PRESSURE OF MORE THAN FIVE POUNDS. DURING TRANSITION FROM HOLD TO RELEASE, THE DEVICE LOSES PRESSURE ABRUPTLY AND COMPLETELY, RESULTING IN REPORTED DISCOMFORT TO THE PATIENT'S NECK. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.