NICVIEW 2.0 CAMERA

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). D4. UDI NUMBER IS NOT APPLICABLE. THE CUSTOMER SENT BACK THE COMPLETED ADVERSE EVENT QUESTIONNAIRE. THE CUSTOMER STATES THAT THE REGISTERED NURSE (RN) WAS ADJUSTING THE CAMERA/ARM OVER THE INFANTS ISOLATE FOLLOWING THE COMPLETION OF CARE AND THE CAMERA/ARM FELL FROM THE WALL MOUNT. ONCE IT FELL NEAR THE PARENT WHO WAS SITTING NEAR THE INFANT'S BED, BUT IT DID NOT STRIKE OR HIT THEM. IT LANDED ON THE FLOOR NEAR THEIR FEET. THE SECOND TIME IT FELL FROM THE REGISTER NURSE'S HANDS TO THE FLOOR BUT THERE WERE NO INJURIES. THE CUSTOMER CONFIRMED THERE WAS NO DEATH OR SERIOUS INJURY. THE RN WAS ADJUSTING THE CAMERA/ARM BY MANIPULATING THE ARM AND IT CAME LOOSE FROM THE WALL MOUNT AND FELL TO THE GROUND. THERE WAS NO INJURY TO STAFF OR PATIENT. THE CUSTOMER CONFIRMED THEY DO NOT HAVE THE SERIAL NUMBER AS THIS OCCURRED IN JULY. THE CAMERA/ARM ARE MOUNTED TO A NON-NATUS HSE IM310-PM-FAIR IV-POLE SING ARM AFFIXED TO THEIR HEADWALL 12-OCTOBER-2022: THE CUSTOMER DOES NOT HAVE THE SERIAL NUMBER OF THE CAMERAS INVOLVED IN THE TWO EVENTS. THE 2 INCIDENTS OF THE CAMERA FALLING ARE NOT RECENT, THEY OCCURRED IN JULY. BECAUSE THE CUSTOMER DOES NOT HAVE THE SERIAL NUMBER OF THE CAMERAS, IT'S NOT POSSIBLE TO DETERMINE WHICH SPECIFIC CAMERAS WERE INVOLVED IN THE 2 INCIDENTS. THEREFORE, THE COMPLAINT WILL BE CLOSED WITHOUT THE PRODUCT BEING EVALUATED. THIS COMPLAINT DOES NOT IDENTIFY A DEFICIENCY IN THE PRODUCT DESIGN AND THEREFORE A CAPA IS NOT REQUIRED 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 FAILLURE CONFIRMED?: NO. INVESTIGATION RESULT CODE: NEURO SBU/PRODUCT NOT RETURNED. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MATERIALS NOT RETURNED FOR ANALYSIS. BASED ON EVALUATION OF THIS COMPLAINT THERE IS NO SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

Description of Event or Problem

NICVIEW 2.0 CAMERA - DURING AN ESCALATION CALL, THE CUSTOMER REPORTED 2 INCIDENTS OF CAMERAS FALLING. ONE CAMERA FELL AND LANDED ON A FAMILY MEMBER OF THE PATIENT AND THE OTHER CAMERA FELL TO THE GROUND. THE CUSTOMER UNINSTALLED THE DEVICES AFTER DEEMING THE EQUIPMENT TO BE UNSAFE. FIELD SERVICE TO GO ONSITE TO INSPECT THE EQUIPMENT, REPLACE THE DEFECTIVE EQUIPMENT, AND REINSTALL. NO INJURIES REPORTED. AE-10208445 OPENED FOR 1ST CAMERA.

Description of Event or Problem

NICVIEW 2.0 CAMERA - DURING AN ESCALATION CALL, THE CUSTOMER REPORTED 2 INCIDENTS OF CAMERAS FALLING. ONE CAMERA FELL AND LANDED ON A FAMILY MEMBER OF THE PATIENT AND THE OTHER CAMERA FELL TO THE GROUND. THE CUSTOMER UNINSTALLED THE DEVICES AFTER DEEMING THE EQUIPMENT TO BE UNSAFE. FIELD SERVICE TO GO ONSITE TO INSPECT THE EQUIPMENT, REPLACE THE DEFECTIVE EQUIPMENT, AND REINSTALL. NO INJURIES REPORTED. AE-10208445 OPENED FOR 1ST CAMERA.

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT# (B)(4). UDI NUMBER IS NOT APPLICABLE. TECHNICAL SUPPORT IS WAITING FOR THE CUSTOMER TO RESPOND TO THE QUESTIONNAIRE. RISK MANAGEMENT FILE REVIEW: PER (B)(4) NICVIEW 2 RISK ANALYSIS, HAZARD ID - 6.6, SEVERITY 11 - CRITICAL, THE RISK IS CONSIDERED MODERATE. FURTHER INVESTION TO BE CARRIED OUT.