Description of Event or Problem · 1
THE PROBLEM WAS DESCRIBED AS A HEAD PIECE OF THE OPERATING TABLE DROPPING DOWN WHILE THE PATIENT'S HEAD WASA RESTING ON IT, CAUSING THE PATIENT'S NECK TO EXTEND. THIS CAUSED THE STERILE DRAPES TO COME LOOSE FROM THE PATIENT'S CHEST WHICH WAS ALREADY OPENED AND EXPOSED AND COMPROMISED THE STERILE FIELD. THE STERILE LAP SPONGE WAS SOAKED IN BETADINE ANAD WAS PLACED OVER THE EXPOSED AREA FOR THE ENTIRETY OF THE CASE. NO APPARENT ADVERSE INJURY HAS BEEN REPORTED AS A RESULT OF THIS INCIDENTDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-JAN-93. 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. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE TEMPORARILY REMOVED FROM SERVICE, OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.