Description of Event or Problem · 0
IT WAS REPORTED THAT DURING USE, THE PATIENT WAS DELIVERED, AND THE MIDWIFE PLACED THE PULSE OXIMETER ON THE RADIANT WARMER AND CONNECTED IT TO THE PATIENT. AFTER THE PROBE WAS CONNECTED TO THE PATIENT¿S LEFT HAND, THE DISPLAY SHOWED NORMAL READINGS. WHEN THE POWER CABLE WAS CONNECTED TO THE DEVICE DUE TO A LOW BATTERY, A SUDDEN ¿BANG¿ SOUND WAS HEARD. THE PULSE OXIMETER PROBE AND THE NEONATE¿S WRIST APPEARED BLACKENED WITH SMOKE RESIDUE. AT THAT TIME, THE NEONATE SHOWED NO IMMEDIATE ABNORMAL REACTION AT THE WRIST. THE MIDWIFE IMMEDIATELY REMOVED THE PULSE OXIMETER, WIPED THE NEONATE¿S ARM WITH SALINE-SOAKED GAUZE, AND EXAMINED THE AREA TOGETHER WITH THE FAMILY MEMBERS. THE PULSE OXIMETER WAS INSPECTED BY LOGISTICS MAINTENANCE PERSONNEL, AND NO ABNORMALITIES WERE FOUND IN THE DEVICE. HOWEVER, THE POWER CABLE WAS FOUND TO BE DAMAGED AND WAS IMMEDIATELY REPLACED. SUBSEQUENT TESTING SHOWED NORMAL DEVICE FUNCTION. THERE WAS NO PATIENT INJURY. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".