NICVIEW

Description of Event or Problem

PART ARM-002 - LONG (39.5" = 100CM) ASSY. - CUSTOMER REPORTED THE CAMERA MOUNT AND ARM FELL OFF THE WALL. THE FOLLOW UP E-MAIL MENTIONED THAT THE CAMERA MOUNT ALMOST FELL ON A PATIENT BUT THE NURSE CAUGHT IT. NO INJURIES.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 (REF NATUS COMPLAINT# (B)(4) ). INITIAL INVESTIGATION BY ENGINEERING CONFIRMED THIS IS THE SAME ISSUE SEEN ON CAPA004584 - CUSTOMER RESOLUTION CONSISTS OF NATUS PROVIDING RETROFIT KITS FOR EACH OF THE AFFECTED CLAMPS. THE RETROFIT KIT CONSISTS OF ONE SCREW FOR EACH NICVIEW CLAMP AND WILL INCLUDE INSTALLATION INSTRUCTIONS. INSTALLATION CONSISTS OF REMOVING THE SMALL CENTER SCREW FROM THE ARM-MOUNTING CLAMP AND REPLACING IT WITH A SHORTER SCREW. IN ADDITION CUSTOMERS ARE PROVIDED WITH A MOUNTING PIN IF REQUIRED TO RESOLVE THE BROKEN ARM. PER QMS-004442, COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS FAILURE CONFIRMED: YES. INVESTIGATION RESULT CODE: NEURO SBU/LOSS OF MECHANICAL INTEGRITY.

Description of Event or Problem

PART ARM-002 - LONG (39.5" = 100CM) ASSY. - CUSTOMER REPORTED THE CAMERA MOUNT AND ARM FELL OFF THE WALL. THE FOLLOW UP E-MAIL MENTIONED THAT THE CAMERA MOUNT ALMOST FELL ON A PATIENT BUT THE NURSE CAUGHT IT. NO INJURIES.

Additional Manufacturer Narrative

INITIAL REPORT (REF NATUS COMPLAINT# (B)(4)). PER HAZARD ID B2 OF (B)(4)- RISK ANALYSIS FOR NICVIEW, THE RISK IS CONSIDERED LOW. SEVERITY 3 - MODERATE. A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. TECHNICAL SUPPORT SENT THE CUSTOMER A AE QUESTIONNAIRE TO OBTAIN ADDITIONAL INFORMATION ABOUT THE INCIDENT. AFFECTED PRODUCT HAS BEEN REQUESTED TO BE RETURNED FOR EVALUATION.