Description of Event or Problem · 1
RESIDENT WAS CONGESTED AND CYANOTIC. TAKEN TO HIS ROOM AND PUT TO BED. RN BROUGHT SUCTION MACHINE IN. CONNECTED TUBING TO BOTTLE PORT LABELED TO PATIENT. TESTED IN GLASS OF H2O. MACHINE WAS BLOWING INSTEAD OF SUCTIONING. ATTEMPTED TO CONNECT MACHINE TUBING FROM BOTTLE TO THE ASPIRATING SITE OF MACHINE. UNABLE TO CONNECT - CONNECTOR (METAL) WAS MISSINGDEVICE NOT LABELED FOR SINGLE USE. 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-JAN-92. SERVICE PROVIDED BY: DISTRIBUTOR. 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, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, FAILURE TO SERVICE/MAINTAIN ACCORDING TO MANUFACTURER RECOMM, CONNECTOR OR ADAPTOR. CONCLUSION: DEVICE FAILED DURING ASSEMBLY, DEVICE FAILURE INDIRECTLY CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, USER EDUCATION PROVIDED, INSERVICED BY MANUFACTURER/DISTRIBUTOR REPRESENTATIVE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.