NV 2.X ARM

Additional Manufacturer Narrative

INITIAL REPORT REF NATUS COMPLAINT#(B)(4). SECTION D4. UDI# AND LOT NUMBER NOT APPLICABLE. A QUESTIONNAIRE HAS BEEN SENT TO THE CUSTOMER FOR MORE DETAILS AND A REPLACEMENT PART WAS SENT TO THE CUSTOMER. FURTHER INVESTIGATION TO BE CARRIED OUT.

Description of Event or Problem

PART NVARM - ARM IS DROOPY AND STRUCK A NURSE IN THE HEAD.

Description of Event or Problem

PART NVARM: ARM IS DROOPY AND STRUCK A NURSE IN THE HEAD.

Additional Manufacturer Narrative

FOLLOW UP REPORT 001 REF NATUS COMPLAINT#: (B)(4). PER (B)(4) REV J NICVIEW 2.0 RISK ANALYSIS SPREADSHEET (RAS) HAZARD ID 6.7 - ARM ASSEMBLY FAILS DUE TO EXCESSIVE STATIC LOADS OR WEAR AND SAGS EFFECTS (HARM) - INJURY TO USER, PATIENT OR LOSS OF FUNCTION DUE MISFRAMED VIDEO. THE HAZARDS IDENTIFIED HAVE RBA RATING OF LOW AND ARE DEEMED BROADLY ACCEPTABLE. THESE RISKS HAVE BEEN REVIEWED TO DETERMINE IF ANY FURTHER CONTROL MEASURES MAY BE IMPLEMENTED SO AS TO FURTHER REDUCE THE RISK AS FAR AS POSSIBLE. RISK OUTWEIGHED BY BENEFIT OF USE OF DEVICE. NO RELATED CAPAS. INVESTIGATION RESULTS: DEFECTIVE CAMERA WAS RETURNED WITHOUT THE ALLEGED DEFECTIVE ARM, UNABLE TO COMPLETE EVALUATION. NO ADDITIONAL PICTURES PROVIDED TO CONFIRM THE FAILURE. ROOT CAUSE/PROBABLE ROOT CAUSE: KNOWN ISSUE - NVARM IS PHASED OUT AND IT IS BEING REPLACED BY NVARM2.