UPPER MAST ASSEMBLY FOR ERGOJUST CART

Additional Manufacturer Narrative

INITIAL REPORT REF TO NATUS COMPLAINT (B)(4). UDI# NOT APPLICABLE. FURTHER INVESTIGATION TO BE CARRIED OUT.

Description of Event or Problem

UPPER MAST ASSEMBLY FOR ERGOJUST CART - CAMERA FELL OFF PORTABLE MACHINE (BRACKET BROKE). CUSTOMER REPORTED THE BROKE CAMERA FELL OFF AND POSSIBLY HIT OPERATOR IN THE HEAD.

Description of Event or Problem

UPPER MAST ASSEMBLY FOR ERGOJUST CART - CAMERA FELL OFF PORTABLE MACHINE (BRACKET BROKE). CUSTOMER REPORTED THE BROKEN CAMERA FELL OFF AND POSSIBLY HIT OPERATOR IN THE HEAD.

Additional Manufacturer Narrative

FOLLOW REPORT 001 REF TO NATUS COMPLAINT #(B)(4). PER (B)(4) REV 78 XLTEK EEG/PSG 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 NO RELATED CAPAS. INSTALL DATE OF AFFECTED DEVICE: DEC 10, 2022. VARIOUS FOLLOW UP ATTEMPTS WERE MADE TO GET THE CUSTOMER TO COMPLETED OUR AE QUESTIONNAIRE BUT NO RESPONSE FROM THE CUSTOMER. JAN 29, 2025 - NATUS ONSITE SERVICE WENT ONSITE TO INVESTIGATE THE INCIDENT. THEY COULD NOT PROVIDE WITH ANY SPECIFIC INFORMATION. ONSITE SERVICE STATED THAT MODIFICATIONS WAS MADE TO THE SYSTEM INSTEAD OF CONTACTING NATUS TO REPORT THE BROKEN CAMERA POST. CUSTOMER INFORMED NATUS THAT IT WAS DONE BY THE GROUP WHO NO LONGER WORKS THERE. THEY ACKNOWLEDGED PROTOCOL NOT FOLLOWED. ONSITE SERVICE REPLACED THE PART. MAR 13, 2025 - CUSTOMER CONFIRMED THAT THE UNIT WAS DISCARDED AND NO FURTHER INVESTIGATION COULD BE MADE.