8400 ST VOLUME VENTILATOR
Received Apr 9, 1993 · Event occurred Jan 26, 1993
Report 5452 · MDR key 5452
Device
Narrative
Description of Event or Problem
VENTILATOR STOPPED SUDDENLY. NURSE GAVE MANUAL BREATHS WITH AMBU BAG UNTIL BACKUP VENTILATOR WAS PLACED BY RESPIRATORY THERAPISTDEVICE 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-DEC-92. SERVICE PROVIDED BY: OTHER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, INVALID DATA. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE REPAIRED AND PUT BACK IN SERVICE, DEVICE TEMPORARILY REMOVED FROM SERVICE. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.