SINGLE-PATIENT-USE DISPOSABLE ECG 3, 5, 6 LEAD SETS

Additional Manufacturer Narrative

VISUAL INSPECTION OF THE LEAD SET FOUND THAT THE LEAD SET HAS BURN DAMAGED ON WIRE FOR THE YELLOW GRABBER. IT CANNOT BE CONFIRMED IF THE CABLE IS FATIGUED, OR DAMAGE WAS CAUSED BY TENSION ON THE LEAD SET. AT THAT THIS TIME NO FURTHER INFORMATION WAS MADE AVAILABLE. IT WAS STATED THAT THE CUSTOMER ONLY HAD A FEW OF THESE OLD PATIENT CABLES LEFT FROM 2020 AND NOTED TO THE CUSTOMER TO NOT TO USE THEM ANYMORE AS THEY EXPIRED. BASED ON THE INFORMATION AVAILABLE AND VISUAL INSPECTION, THE CAUSE OF THE REPORTED PROBLEM WAS RELATED TO BE EXPIRED CABLES. PHILIPS CANNOT CONFIRM HOW DAMAGE TO THE LEAD SET OCCURRED BUT HAS DETERMINED THAT THE EXPOSED WIRE IS HAZARDOUS. HOWEVER, IT WAS STATED THAT THE CABLES WERE OLD PATIENT CABLES THAT WERE USED AT THE TIME OF THE EVENT. PER THE INSTRUCTIONS FOR USE (IFU) STATES "TO INSPECT ALL ACCESSORIES (CABLES, TRANSDUCERS, SENSORS AND SO FORTH). IF ANY SHOW SIGNS OF DAMAGE, OR THE USE-BY DATE HAS BEEN EXCEEDED, DO NOT USE."

Additional Manufacturer Narrative

AFTER FURTHER INVESTIGATION IT WAS DETERMINED THAT THE CUSTOMER STATED THAT THE PATIENT THE BURN WAS NOT LIFE-THREATENING, DID NOT REQUIRE MEDICAL INTERVENTION AND THE PATIENT WAS DISCHARGED WITH NO FURTHER HARM. THE CUSTOMER WAS USING THE PATIENT CABLES THAT HAD EXPIRED AND WAS INSTRUCTED TO DISCARD AND EXPIRED CABLES, HOWEVER RETURN THE CABLE THAT WAS IN USE FOR FURTHER EVALUATION. AT THAT THIS TIME NO FURTHER INFORMATION WAS AVAILABLE.

Description of Event or Problem

IT WAS LATER CONFIRMED THERE WAS NO ADVERSE EVENT. THE BURN WAS NOT LIFE-THREATENING, AND THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION. IT WAS STATED THAT THE PATIENT HAD A LARGE PHYSIQUE WHICH COULD HAVE INTERFERED WITH THE CABLES AND THE PATIENT WAS DISCHARGED WITH NO FURTHER HARM OR TREATMENT.

Additional Manufacturer Narrative

PHILIPS IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURN FROM THE ELECTRODE CABLE. THE CABLE APPEARED TO HAVE CUTS AND WAS REPORTED TO BE YELLOWED AND DIRTY. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTION WAS REPORTED. BASED ON DETAILS AVAILABLE AT THE TIME OF THIS REVIEW, THERE IS INSUFFICIENT INFORMATION TO DETERMINE WHETHER THE REPORTED HARM MEETS CRITERIA FOR SERIOUS INJURY. THEREFORE, ADDITIONAL INFORMATION HAS BEEN REQUESTED.