Description of Event or Problem · 1
ON 11/20/92 THE RESIDENT WAS READMITTED TO THE FACILITY AT 10:30 A.M. THE RESIDENT WAS AWAKE, ALERT, IN FAIR CONDITION. SHE HAS MULTIPLE RESPIRATORY DIAGNOSIS, SHE WAS PLACED ON 4L OF CONTINOUS OXYGEN VIA NASAL CANNULA. AT 12:00, SHE COMPLAINED OF SHORTNESS OF BREATH BUT FURTHUR ASSESSMENT WAS NEGATIVE FOR DIFFICULTIES. AT 1:30 P.M. SHE WAS UNRESPONSIVE, CYANOTIC AND UNSTABLE. UPON FURTHER ASSESSMENT, THE OXYGEN CONCENTRATOR, WHICH ALSO HAD A BUBBLE HUMIDIFIER (MANUFACTURER SALTER LABS) WAS CHECKED. THE TUBING WAS REMOVED FROM THE HUMIDIFIER CONNECTION - THERE WAS NOT ANY DISCERNABLE OXYGEN FLOW COMING FROM THE HUMIDIFIER. THE RESENT WAS THEN PLACED ON A DIFFERENT OXYGEN CONCENTRATOR WITHOUT A HUMIDIFIER. THIS DID NOT HELP, SO HER OXYGEN WAS INCREASED TO 6L/MIN. SHE EXPIRED APPROXIMATELY 15 MINUTES LATER. THE ORIGINAL CONCENTRATOR AND HUMIDIFIER WERE REASSEMBLED AND CHECKED WHICH SHOWED THEM TO BE PROPERLY WORKING. THE EVENT WAS NOT REPRODUCABLEDEVICE 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: . SERVICE PROVIDED BY: DISTRIBUTOR. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.