CSM DESKTOP POWER SUPPLY

Additional Manufacturer Narrative

THE CONNEX SPOT MONITORS ARE INTENDED TO BE USED BY CLINICIANS AND MEDICALLY QUALIFIED PERSONNEL FOR MONITORING OF NONINVASIVE BLOOD PRESSURE, PULSE RATE, NONINVASIVE FUNCTIONAL OXYGEN SATURATION OF ARTERIOLAR HEMOGLOBIN (SPO2), AND BODY TEMPERATURE IN NORMAL AND AXILLARY MODES OF NEONATAL, PEDIATRIC AND ADULT PATIENTS. MONITORING RESPIRATION RATE FROM PHOTOPHLETHYSMOGRAM (MASIMO RRP) IS INDICATED FOR ADULT AND PEDIATRIC PATIENTS GREATER THAN TWO YEARS OLD. THE MOST LIKELY LOCATIONS FOR PATIENTS TO BE MONITORED ARE GENERAL MEDICAL OR SURGICAL FLOORS AND GENERAL HOSPITAL AND ALTERNATE CARE ENVIRONMENTS. THIS PRODUCT IS AVAILABLE FOR SALE ONLY UPON THE ORDER OF A PHYSICIAN OR LICENSED HEALTH CARE PROFESSIONAL. THE DEVICE WAS RETURNED FOR INSPECTION WHERE IT WAS DETERMINED THAT THE POWER CORD AND POWER SUPPLY HAD BURN DAMAGE. THE POWER CORD AND POWER SUPPLY WILL BE REPLACED FOR THE CUSTOMER. ALTHOUGH THERE WAS NO REPORTED INJURY WITH THIS EVENT, IF THE REPORT OF BURNED DEVICE AND SPARK WERE TO RECUR, IT COULD POTENTIALLY CAUSE SERIOUS INJURY OR DEATH. THEREFORE, BAXTER IS REPORTING THIS EVENT.

Description of Event or Problem

CUSTOMER REPORTED THE STAFF NOTICED THE END OF CABLE WAS BURNT AND SMELT OF BURNING. THE DEVICE WAS THEN PLUGGED BACK IN TO A DIFFERENT MAINS LEAD WHICH THEN CAUSED THE MACHINE AT THE CONNECTOR TO SPARK. THERE WAS NO PATIENT/USER INJURY, MEDICAL INTERVENTION, SYMPTOM, OR ADVERSE EVENT REPORTED.