TRITON DTS

Additional Manufacturer Narrative

THE EVALUATION REVEALED THAT THE ROPE HAD MISALIGNED WITH THE PULLEY ASSEMBLY ADJACENT TO THE DEVICE LOAD CELL. MISALIGNMENT IS TYPICAL OF PRODUCT MIS-USE AND/OR PRODUCT MIS-HANDLING. THE DEVICE USER MANUAL, AS ATTACHED, SPECIFICALLY INDICATES NOT TO MIS-USE AND/OR MIS-HANDLE PRODUCT, NOT TO USE PRODUCT IF ERRORS APPEAR, AND INSPECT THE PRODUCT PRIOR TO EACH USE.

Description of Event or Problem

THERAPIST WAS PROVIDING CERVICAL TRACTION WHEN THE ROPE JUST RELEASED. THERAPIST MENTIONED THAT THE UNIT HAD A CONSTANT HUMMING SINCE THE DAY IT WAS UNBOXED AND PLACED INTO SERVICE. THE HUMMING WAS CONSTANT LIKE THAT OF A PC FAN RUNNING. AS CONVEYED, THE UNIT WAS IN PROGRESS OF A CERVICAL TRACTION WHEN THE UNIT APPEARED TO ERROR AND RELEASED THE PATIENT FROM TREATMENT. THE UNIT DID HAVE ERROR 309 TWICE PRIOR TO THE EVENT. THERE WAS NO REPORT OF PATIENT INJURY.