MalfunctionITH
TRITON DTS ADVANCED ACCESSORY PACKAGE
Received Jun 18, 2021 · Event occurred May 19, 2021
Report 9616086-2021-00008 · MDR key 12029111
Product problems
- Unintended System Motion
- Unintended System Motion
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
IT WAS REPORTED BY THE CLINIC THAT WHEN PATIENTS ARE ON LUMBAR DECOMPRESSION, THE MAX POUNDS ALLEGEDLY RAMPS ABOVE THE CLINICIAN'S SETTING. IT WAS REPORTED THAT THE CLINICIANS DO NOT SEE ANY ERROR CODE. THERE WAS NO PATIENT INJURY OR ADVERSE CONSEQUENCE REPORTED. DJO HAS MADE MULTIPLE ATTEMPTS TO OBTAIN FURTHER INFORMATION WITHOUT ANY RESPONSE. IF THE PRODUCT IS RETURNED FOR EVALUATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED BY THE CLINIC THAT WHEN PATIENTS ARE ON LUMBAR DECOMPRESSION, THE MAX POUNDS ALLEGEDLY RAMPS ABOVE THE CLINICIAN'S SETTING.