Description of Event or Problem · 1
ON 2/13/93 A 3 MONTH OLD MALE PATIENT WAS ADMITTED TO UNIVERSITY HOSPITAL FOR SEIZURE DISORDER/HYPOCALCEMIA. AT 1300 HOURS ON 2/21/93 WHILE THE PATIENT WAS ON AN AIR SHILEDS RESPIRATION RATE MONITOR, THE PATIENT WAS FOUND TO BE BLUE AND APNEIC. A CODE WAS CALLED AND EFFORTS TO RESUSCITATE WERE ADMINISTERED. THE RESUSCITATION WAS NOT SUCCESSFUL.THE PURPOSE OF THIS REPORT IS TO INFORM THE MANUFACTURER (OF THE APNEA MONITOR) THAT THE DEVICE WAS ASSOCIATED WITH THE PATIENT'S DEATH IN THAT THE AUDIBLE ALARM DID NOT SOUND AS A RESULT OF THE RESPIRATION RATE DECREASING. OUR CONCERN IS THAT THE AUDIBLE ALARMS ON THE AIR SHIELDS MONITORS CAN BE SILENCED WITHOUT THE FEATURE OF AUTOMATIC SELF-ACTIVATION AFTER A TIME INTERVAL.ALL AIRSHIELD RESPIRATION RATE MONITORS HAVE BEEN PERMANENTLY REMOVED FROM SERVICEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-SEP-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS, INVALID DATA. CONCLUSION: NO FAILURE DETECTED BUT PRODUCT OUT OF SPECIFICATION, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, USE OF ALL SIMILAR DEVICES STOPPED PERMANENTLY, USER EDUCATION PROVIDED. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.