NMT CABLE

Additional Manufacturer Narrative

A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

IT WAS REPORTED FOLLOWING SURGERY, A SMALL BURN WAS NOTED ON THE RIGHT HAND NEAR THE BASE OF THE THUMB ON THE NON-PALM SIDE. THE BURN WAS APPROXIMATELY 5MM IN DIAMETER, WITH THE CENTER PENETRATING DEEPER INTO THE SKIN AND THE OUTSIDE CIRCUMFERENCE REDDENED. THE PHYSICIAN DID NOT CLASSIFY THE BURN AND THE FELLOW APPLIED BACITRACIN OINTMENT WITH A XEROFORM DRESSING. IT WAS INDICATED THERE WILL LIKELY BE PERMANENT DAMAGE, THOUGH SMALL.

Additional Manufacturer Narrative

PATIENT INVOLVEMENT WAS REPORTED. FOLLOWING SURGERY, A SMALL BURN WAS NOTED ON THE THUMB WHERE THE NMT CABLE CAME INTO CONTACT WITH THE PATIENT. BACITRACIN OINTMENT WAS APPLIED WITH A XEROFORM DRESSING. IT WAS INDICATED THERE WILL LIKELY BE PERMANENT DAMAGE, THOUGH SMALL. THE CUSTOMER STATED THAT THEY OPENED THIS CASE TO MAKE A RECORD OF THE INCIDENT, THE PATIENT'S HEALTH IS FINE DESPITE RECEIVING A SMALL BURN FROM AN EXPOSED WIRE ON THE CABLE. THE CUSTOMER ALSO INDICATED THAT IT WAS UNDERSTOOD THAT PHILIPS WILL REFER TO THE INFORMATION FOR USE (IFU) THAT SAYS ¿INSPECT THE NMT CABLE FOR DAMAGE PRIOR TO AND DURING MONITORING. USING A DAMAGED NMT CABLE ON A PATIENT COULD CAUSE BURNS". THE CUSTOMER FELT THAT TRAINING IS GENERALLY A WEAK MITIGATION ESPECIALLY FOR CLINICAL STAFF WHO HAVE TOO MUCH TO REMEMBER ALREADY. THE PICTURES PROVIDED BY THE CUSTOMER WERE SENT TO THE PHILIPS PRODUCT SUPPORT ENGINEER (PSE) FOR REVIEW. THE PSE STATED THAT THE PHILIPS IFU CLEARLY STATES A WARNING NOT TO USE A DAMAGED CABLE (REFER TO 989803199211 INTELLIVUE NMT HAND-ADAPTER - INSTRUCTIONS FOR USE, PAGE 5, WARNING STATES "DO NOT USE IF VISUAL INSPECTION REVEALS DAMAGE OR CONTAMINATION"). THE CABLE UNDER THIS CASE WAS DAMAGED WITH EXPOSED WIRES. IN THIS APPLICATION THE PATIENT IS UNDER SEDATIVES AND CAN'T ALERT THE MEDICAL STAFF THAT SOMETHING IS WRONG. THE CASE COULD BE CLEARLY AVOIDED BY DISPOSING OF THE DAMAGED CABLE AND REPLACING WITH A NEW ONE. BASED ON THE INFORMATION AVAILABLE, THE CAUSE OF THE REPORTED PROBLEM WAS A DAMAGED CABLE WITH EXPOSED WIRES. THE CUSTOMER WILL BE REMINDED OF THE WARNING IN THE IFU. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.