Description of Event or Problem · 1
THIS PATIENT WAS ADMITTED TO THE INTENSIVE CORONARY CARE UNIT JANUARY 17, 1992 WITH AN ACUTE MYOCARDIAL INFARCTION. HE WAS TRANSFERRED TO THE INTERMEDIATE CORONARY UNIT ON JANUARY 19, 1992. ON JANUARY 20, 1992, THE PATIENT DEVELOPED A RASH AROUND THE AREA OF THE ELECTRODE FOR CARDIAC MONITORING. THIS PATIENT WAS ON MULTIPLE DRIPS AND REQUIRED DEFIBRILLATING IN THE EMERGENCY ROOM WHERE SALINE FILLED DEFIBRILLATOR PADS WERE USED. THIS PATIENT HAS A HISTORY OF CONTACT DERMATITIS. THIS REACTION WHICH STARTED AROUND THE ELECTRODE AREA WAS SO SEVERE THAT THE PATIENT REQUIRED INTRAVENOUS CORTISONE THERAPY; TOPICAL CREAMS AND SOAKS WITH A DERTATOLOGY CONSULT. OPEN HEART SURGERY WAS RECOMMENDED FOR THE PATIENT BUT WAS POSTPONED 4-5 DAYS UNTIL THE GENERALIZED RASH DISAPATED ENOUGH THAT SURGERY COULD BE PERFORMED. ONE OF HIS DISCHARGE DIAGNOSES WAS "MASSIVE ALLERGIC REACTION" TO THE ECG ELECTRODES. THIS INCIDENT WAS PICKED UP ON MEDICAL RECORD REVIEW MARCH 4, 1992. NURSE MANAGER OVER ADULT CRITICAL CARE UNIT PROVIDED REPORT MARCH 10, 1992DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS DESTROYED/DISPOSED OF.