NICVIEW 2.0 CAMERA
Received Jun 28, 2021 · Event occurred Jun 11, 2021
Report 9612330-2021-00002 · MDR key 12077469
Device
Product problems
- Break
- Connection Problem
- Break
- Connection Problem
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DAMAGED CAMERA/PWRSUPPLY CONNECTION. (NICVIEW 2.0 CAMERA) SPARKS WHEN TRYING TO PLUG BACK IN. NO PATIENT INVOLEMENT.
Additional Manufacturer Narrative
FOLLOW UP REPORT 001 REF NATUS COMPLAINT# (B)(4). THE AFFECTED UNIT WAS RECEIVED INTO MIDDLETON. EXAMINATION AND TESTING WAS NOT PERFORMED BECAUSE FACTORY SERVICE DOES NOT SERVICE NICVIEW 2 PRODUCTS. CAPA005201 IS RELATED TO THIS COMPLAINT. CORECTIVE ACTION PLAN: NICVIEW 2.0 - IMPROVEMENT TO THE MICROUSB (POWER CABLE END) AT THE BASE OF THE NICVIEW 2 ARM. NICVIEW 2.0 - IMPROVEMENT TO THE MICROUSB (POWER CABLE) AT CAMERA END CREATED TO DESIGN PROTECTION FOR THE MICROUSBS. RISK ASSESSMENT WAS CONDUCTED AND RELEASED ON DOC-055534 REV 01 NICVIEW 2 MICRO-USB DAMAGE POST MARKET RISK ASSESSMENT. PREVENTIVE ACTION PLAN: INSTALL BRACKET, PN 036431, ON THE ARM USING SCREWS INSTEAD OF ADHESIVE AT THE MANUFACTURER. INVESTIGATION RESULT CODE: NEURO SBU/CONNECTOR DAMAGED. THIS COMPLAINT WAS VERIFIED, CAPA005201 ALREADY OPEN. 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. PER (B)(4) COMPLAINT HISTORIES ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS AND ANY COMPLAINT TRENDS ARE ASSESSED AND DOCUMENTED AS PART OF THESE REVIEWS. PER DOC-023354 LINE 2.2 SEVERITY 11- ACCEPTABLE RESIDUAL RISK LEVEL. 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. A SEARCH FOR SERVICE DATA THAT MAY HAVE BEEN RELEVANT TO THIS ISSUE WAS CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE WAS FOUND.
Additional Manufacturer Narrative
INITIAL REPORT REF NATUS COMPLAINT# (B)(4). CAM #3, MAC: B8:27:EB:65:4E:51, BROKEN CAMERA/PWRSUPPLY PORT SPARKS WHEN TRYING TO PLUG BACK. NO PATIENT INJURY. DAMAGED NVCAM RETURNING BACK TO MIDDLETON FOR EVALUATION.
Description of Event or Problem
DAMAGED CAMERA/PWRSUPPLY CONNECTION. (NICVIEW 2.0 CAMERA) SPARKS WHEN TRYING TO PLUG BACK IN. NO PATIENT INVOLVEMENT.