D
Patient 1
PATIENT WAS ATTACHED TO MONITOR. NURSE OBSERVED THE BABY TO BE CYANOTIC WITH NO RESPIRATIONS. HEART RATE BY MONITOR WAS 100. NO ALARMS SOUNDED. BABY WAS SUCESSUFULLY RESUSCIATED. THE TEST/CAL BUTTON ON THE MONITOR WAS FOUND TO BE IN A DEPRESSED POSITION WHICH CREATED THE TEST FUNCTION OF 100 BEATS PER MINUTE TO OCCUR ON MONITOR, EVEN THOUGH BABY'S HEART RATE WAS BELOW THAT. THE TEST/CAL BUTTON WAS LODGED IN DEPRESSED POSITION WITH A PIECE OF PAPERDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-APR-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, COMPUTER SOFTWARE PERFORMANCE TESTS CONDUCTED, PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS, MODIFICATION OF DEVICE - BY USER, NONE OR UNKNOWN. CONCLUSION: USER ERROR CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INSERVICED BY BIOMEDICAL ENGINEERING DEPT. STAFF. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.