Description of Event or Problem · 1
WHEN INFLATING BALLOON DURING PROCEDURE USING THE MICROVASIVE LAVEEN INFLATOR WITH DILATION MONITOR, WE LOST ALL PRESSURE AND BALLOON DEFLATED AND WHEN THE BALLOON WAS TAKEN OUT FROM SCOPE, BALLOON WAS DEFLATED WITH NO PRESSURE. IT WAS ASSUMED THE BALLOON HAD BURST SINCE IT WOULD NOT REINFLATE. PSI WAS APPROXIMATELY UP TO 40, BUT MANUFACTURER OF BALLOON CALLED FOR A MAXIMUM OF 43 TO GET THE ADEQUATE PRESSURE NEEDED. WE GOT ANOTHER BALLOON AND SAME THING HAPPEN ALSO USING THE LAVEEN INFLATOR AND MONITOR. PRODUCT WAS USED IN ENDOSCOPY LAB AS A ESOPHASEAL BALLOON AND MANUALLY INFLATED BALLOON AND DID FINE AFTER THE PROBLEM WITH THE FIRST TWO. NO PROBLEMS OCCURRED WITH PATIENT, NO TREATMENT REQUIREDDEVICE NOT 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.