UPPER MAST ASSEMBLY FOR ERGOJUST CART

Additional Manufacturer Narrative

INITIAL REPORT REF TO NATUS COMPLAINT # (B)(4). UDI# AND LOT/SERIAL# NOT APPLICABLE. PER (B)(4) RISK ANALYSIS SPREADSHEET HAZARD ID 6.11 - DUE TO MECHANICAL STRESS OR IMPACT, DYNAMIC LOADING, VIBRATION, OR ENVIRONMENTAL CONDITIONS -- ACCESSORY SHELF ON CART MAY BE UNABLE TO SUPPORT THE MASS OF ACCESSORIES OR ITEMS PLACED ON ITS SURFACE, CAUSING IT TO BEND OR BREAK AND LEAVE SHARP EDGES EXPOSED OR BROKEN SUPPORT SYSTEM COULD LAND ON AND HARM SOMEONE. EFFECTS (HARM) - CRUSHING INJURY. RBA RATING: MEDIUM THE HAZARDS IDENTIFIED HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH A KNOWN STANDARD. AS NOTED IN QMS-000018, HAZARDS THAT HAVE BEEN EVALUATED AND FOUND TO BE IN COMPLIANCE WITH KNOWN STANDARDS CAN BE PRESUMED TO BE CONSISTENT WITH AN ACCEPTABLE LEVEL OF RISK, YIELDING AN ACCEPTABLE RISK / BENEFIT TO THE PATIENT OR USER. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. NO RELATED CAPAS. THE CUSTOMER STATED: ONE OF THE CAMERA TOWERS BROKE AT THE MOUNTING CONNECTION. IT BROKE AT THE WELD ON THE MOUNT BRACKET JUST LIKE THIS TIME.THEY BELIEVE THE EQUIPMENT MOUNTED TO THE TOWER IS TOO HEAVY FOR THE BRACKET THAT ATTACHES TO THE REST OF THE CART. THE SCREWS COME LOOSE FROM VIBRATION OF PUSHING THE CART DOWN THE HALLWAY AND THE TOWER STARTS WOBBLING AND IT DOES THIS UNTIL THE MOUNT BRACKET BREAKS. THEY TRY TO KEEP THE SCREWS TIGHT AND HAVE ASKED THE DEPARTMENT TO EITHER ROUTINELY CHECK AND TIGHTEN THE TOWER MOUNT SCREWS OR INFORM THEM THAT THEY ARE LOOSE SO THEY CAN TIGHTEN THEM. CUSTOMER PROVIDED PHOTOGRAPHS THAT CONFIRMED FAILURE. CUSTOMER WAS UNABLE TO CONFIRM WHEN THE FIRST TOWER BROKE. THE UPPER MAST ASSEMBLY WAS BEING USED ON THE CART ASSOCIATED WITH COMPUTER SN: (B)(6) INSTALL DATE FOR COMPUTER WAS: (B)(6) 2022. NO DEVICE RETURNED; PRODUCT WAS EVALUATED BASED ON PROVIDED PHOTOGRAPHS. ENGINEERING CONFIRMED "THIS IS THE NEW VERSION OF THE MAST; THE SECONDARY FEATURES HAVE ALSO FAILED. THE MAST WOULD HAVE BEEN VISIBLY WOBBLING AROUND FOR A LONG TIME FOR IT TO FAIL LIKE THIS." ALSO THE ERGOJUST CART USER MANUAL 019667 ON PAGE 1-15, IT STATES, "FOR THIS CART, PREVENTATIVE MAINTENANCE CONSISTS OF PERIODICALLY CLEANING AND INSPECTING THE EXTERIOR OF THE INSTRUMENT." IF THEY WOULD HAVE INSPECTED, THEY WOULD HAVE SEEN THIS ISSUE BEFORE IT OCCURRED. FAILURE CONFIRMED: YES. INVESTIGATION RESULT CODE: NEURO SBU/PHYSICAL DAMAGE - USER ERROR. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW.

Description of Event or Problem

UPPER MAST ASSEMBLY FOR ERGOJUST CART -USER STATED THEY WERE PUSHING THE CART DOWN THE HALL AND THE CAMERA TOWER FELL AND ALMOST HIT THEM ON THE HEAD.