CLAMP-001 -NICVIEW

Description of Event or Problem

C-CLAMP - CUSTOMER STATES THAT THEIR CAMERA MOUNTING PINS ARE BROKEN AND THE DEVICE ALMOST FELL ON THE PATIENT. PER CUSTOMER'S ACCOUNT OF THE EVENT: "NICU VISITOR MOVED CAMERA ARM TO ACCESS PATIENT AND CAMERA ARM CLAMP PIN SNAPPED". NO INJURIES REPORTED.

Additional Manufacturer Narrative

INITIAL REPORT REF TO NATUS COMPLAINT #(B)(4). CUSTOMER WAS PROVIDED A LABEL TO RETURN THE PRODUCT TO NATUS FOR EVALUATION. CUSTOMER STATED THERE HAS BEEN PREVIOUS COMPLAINTS ON THIS SAME ISSUE. REVIEW OF CUSTOMER'S ACCOUNT SHOWS SIMILAR DESCRIPTIONS UNDER TECHNICAL SERVICE CASE 10142600, NO OTHER RECENT CASES SHOWS THIS FAILURE. CUSTOMER WAS SENT EQUIPMENT IN RELATION TO FCA (B)(4). ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT PER HAZARD ID LINE B4 IN DOC-019388 RISK ANALYSIS FOR NICVIEW SPREADSHEET, THE RISK IS CONSIDERED LOW. 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. SERVICE REPAIR INVESTIGATIONS WILL BE CONDUCTED DURING THE REPAIR PROCESS AND TREND DATA WILL BE REVIEWED PER QMS-004442. NO UDI NUMBER APPLIES. FURTHER INVESTIGATION TO BE CARRIED OUT.

Description of Event or Problem

C-CLAMP - CUSTOMER STATES THAT THEIR CAMERA MOUNTING PINS ARE BROKEN AND THE DEVICE ALMOST FELL ON THE PATIENT. PER CUSTOMER'S ACCOUNT OF THE EVENT: "NICU VISITOR MOVED CAMERA ARM TO ACCESS PATIENT AND CAMERA ARM CLAMP PIN SNAPPED". NO INJURIES REPORTED.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REPORT REF TO NATUS COMPLAINT# (B)(4). PER DESCRIPTION FROM CUSTOMER: "CAMERA WAS SUSPENDED FROM A STATIONARY IV MOUNT OVER A GE GIRAFFE OMNIBED. PATIENT VISITOR OBSERVED THE CAMERA OVER THE CRIB WAS IN THE WAY. VISITOR PUSHED CAMERA OUT OF THE WAY AND THE MOUNT SNAPPED, CAUSING THE CAMERA TO FALL. VISITOR CAUGHT THE CAMERA BEFORE IT FELL ON THE PATIENT." CUSTOMER BELIEVES FAILURE ATTRIBUTED TO "PIVOT PIN IS A CASTED TYPE WITH A HOLLOW CENTER. WE HAVE HAD 3 BREAK SO FAR." NO MEDICAL INTERVENTION OR ADDITIONAL DELAYS, FAILURE DURING PATIENT VISITATION. PRODUCT EXAMINATION AND FUNCTIONAL TESTING: AFFECTED PRODUCT WAS RECEIVED IN HOUSE. EVALUATION COMPLETED BY ENGINEERING. ENGINEERING CONFIRMED THE MOUNTING SHAFT WAS BROKEN, POSSIBLY CAUSED BY EXPOSURE TO DYNAMIC LOADING OVER TIME. ENGINEERING ALSO NOTED THAT BASED ON THE IFU "THE ARM/CAMERA SHOULD NEVER BE POSITIONED OVER A PATIENT AND THERE SHOULD NEVER BE A RISK OF AN ARM FALLING AND CAUSING AN INJURY IF THIS TYPE OF FAILURE WERE TO RECUR." CAPA TRENDING REVIEW: REFERENCE CAPA004584 FOR NICVIEW ARM FAILURE INVESTIGATION. FAILLURE CONFIRMED:YES. INVESTIGATION RESULT CODE :SEATTLE/HARDWARE FAILURE (MECHANICAL COMPONENT). CLOSURE RATIONALE: COMPLAINT VERIFIED, RESOLVED ON-SITE AND NO FURTHER ACTION NECESSARY. LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.