Description of Event or Problem · 1
INCIDENT OCCURRED JANUARY 25, 1993 - A NEWBORN INFANT BOY (NBICU) SUSTAINED THIRD DEGREE BURNS TO RIGHT (R) EAR AND POSTERIOR NECK SECONDARY TO ALLEGED MALFUNCTION OF BIRD HUMIDIFIER. COMPLAINT WAS THAT UNIT FAILED TO SHUTDOWN AT 40 DEGREE CELSIUS, THE POINT AT WHICH SAFETY CIRCUITS SHOULD HAVE DISABLED UNIT - CONTINUED TOHEAT TO APPROX. 70 DEGREE CELSIUS. CONDITION WOULD PROVIDE OVERHEATED HUMIDIFIED AIR TO THE SITE-IN THIS CASE A FACIAL HOOD. EVALUATION BY BIOMED SENIOR RESPIRATORY EQUIPMENT TECHNICIAN CONFIRMED CONDITION AS STATED BY USER - UNIT DID NOT SOUND AUDIBLE ALARM; HOWEVER UNIT DID ILLUMINATE VISUAL ALARM, A SMALL RED LED THAT MIGHT NOT BE READILY NOTICED - PROBLEM WAS FOUND TO BE A POWER SUPPLY CIRCUIT BOARD-BOARD NORMALLY REPLACED AS UNIT - AUDIBLE ALARM FAILURE SEEMS TO BE UNRELATED PROBLEM - AFTER REPLACING POWER SUPPLY BORAD - UNIT FUNCTIONED NORMALLY - AS CROSS CHECK - BAD BOARD REINSTALLED - OVERHEAT CONDITION RETURNED - AUDIBLE ALARM FUNCTIONED - APPEARS THAT INTERMITTENT FAILURE OF AUDIBLE ALARM UNRELATED TO POWER SUPPLY BOARD FAILUREDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JUL-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: COMPONENT FAILURE, HUMIDIFIER, ALARM FAILURE, FAIL-SAFE SYSTEMS, INTEGRATED CIRCUIT BOARD, POWER SUPPLY. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED 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. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.