TRANSDUCER FILTER
Received Aug 27, 1992 · Event occurred Jul 24, 1992
Report 2243621-1992-00091 · MDR key 1233
Device
Narrative
Description of Event or Problem
TRANSDUCER PROTECTABLE DO NOT PEAL ON MACHINE CAUSING VENOUS CHAMBER TO CONTINUALLY RISE UP AND WET THE MEMBRANE CAUSING IRRATIC AND IRREGULAR PRESSURES AND LMPS. THE UNIT IS CURRENETLY CHANGING TRANSDUCER 5-6 TIMES PER TREATMENT X 15-20 TREATMENTS EBL 120CCDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE 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.