TABLE, VTS, 120VAC

Description of Event or Problem

A CUSTOMER REPORTED THAT A VIBRATORY TABLE WAS EMITTING SMOKE FROM THE REAR OF THE UNIT DURING USE. NO INJURY OR ADVERSE IMPACT TO THE USER WAS REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. A VISUAL INSPECTION IDENTIFIED EVIDENCE OF OVERHEATING ON THE POWER SUPPLY BOARD. THE RETURNED UNIT DID NOT CONTAIN THE UPGRADED COMPONENTS THAT WERE INTRODUCED INTO PRODUCTION IN AUGUST 2021 TO ADDRESS RELIABILITY AND REDUCE THE RISK OF OVERHEATING DURING PROLONGED USE. THE POWER SUPPLY BOARD WAS UPDATED BY REPLACING A RESISTOR AND CAPACITOR. FOLLOWING THE UPDATE, THE UNIT OPERATED SAFELY UNDER TEST CONDITIONS AND WAS RETURNED TO THE CUSTOMER.

Additional Manufacturer Narrative

THIS MDR IS BEING SUBMITTED LATE DUE TO FINDINGS FROM AN INTERNAL AUDIT, WHICH IDENTIFIED THAT CERTAIN COMPLAINTS HAD NOT BEEN ADEQUATELY EVALUATED FOR MDR REPORTABILITY. IN RESPONSE, CAPA 24-08 WAS INITIATED TO ADDRESS AND CORRECT DEFICIENCIES IN THE COMPLAINT HANDLING AND MDR ASSESSMENT PROCESS. AS PART OF A TWO-YEAR RETROSPECTIVE REVIEW CONDUCTED UNDER THIS CAPA, FIVE COMPLAINTS WERE DETERMINED TO MEET MDR REPORTING REQUIREMENTS. THESE REPORTS ARE BEING SUBMITTED ACCORDINGLY.