Description of Event or Problem · 1
59 YEAR OLD WHITE FEMALE WITH C/1 C/2 FRACTURE, VENTILATOR DEPENDENT. AT 9:00 P.M., PATIENT WAS ASSISTED IN THE BED WITH POSITIONING BY NURSING STAFF AND ASSESSED BY RESPIRATORY THERAPIOST. AT 9:40 P.M., PATIENT WAS FOUND CYANOTIC AND UNRESPONSIVE. PATIENT WAS CONNECTED TO AEQUITRON MEDICAL, INC. NURSE ATTEMPTED TO VENTILATE PATIENT WITH AMBU BAG AND RESISTANCE WAS MET. RESPIRATORY THERAPIST ASISSTED. TRACH WAS MANIPULATED SO THAT PATIENT COULD BE VENTILATED. PATIENT'S COLOR RETURNED, PUPILS CONSTRICTED AND WAS NON-RESPONSIVE. TRACH WS CHANGED BY RESPIRATORY THERAPIST AND RECONNECTED TO VENTILATORDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: PERFORMANCE TESTS PERFORMED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN, OTHER. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP, NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.