AMVEX

Description of Event or Problem

EVENT DESC: CHANGE IN PT'S STATUS NOTED - REQUIRING ADDITIONAL OXYGEN AND NASAL FLARING. CHEST TUBE REGULATOR CHANGED, CHEST TUBE DRAINING AND REQUIRING LESS OXYGEN. DID THIS EVENT INVOLVE AN ELECTROPHYSIOLOGY PROCEDURE OR AN ATTEMPTED ELECTROPHYSIOLOGY PROCEDURE? NO.

Additional Manufacturer Narrative

PHONE CALL WAS MADE TO REPORTER ON MAY 29, 2009 AT 1:45PM TO SET UP A CONFERENCE CALL WITH HER TO DISCUSS ON MEDWATCH AND UNABLE TO GET A HOLD OF HER AND LEFT MESSAGE. AMVEX FOLLOWED UP AT 4:30PM AND DID NOT GET TOO MUCH INFO FROM REPORTER, AND SHE REFUSED TO HAVE CONFERENCE CALL WITH US. WE ASKED REPORTER TO SEE IF WE CAN SET UP A CONFERENCE CALL WITH HER AND WITH AMVEX GM TO DISCUSS THE MEDWATCH COMPLAINT SINCE THE INFO FROM MEDWATCH IS NOT CLEAR TO US AND SHE REFUSED TO HAVE CONFERENCE CALL WITH US. REPORTER SAID WHATEVER INFO SHE GOT IS WRITTEN ON THE MEDWATCH. SHE SAID THAT THE INFO IS FROM OTHER PARTY. WE ASKED TO SEE IF WE CAN SET UP A CONFERENCE WITH THE ORIGINAL RPTR AND SHE ANSWERED "NO, WE DON'T DO THIS HERE." THEN I ASKED HER IF THE INFO IS FROM BIOMED DEPT, THEN SHE ANSWERED "NO, IT'S NOT." A FOLLOWING PHONE CALL WAS MADE ON JUNE 2 2009 AT 4:00PM WITH QUALITY ASSURANCE MANAGER AT MEDICAL CENTER. AT FIRST, WE CALLED THE GENERAL PHONE NUMBER TO LOOK FOR ANYONE WHO CAN PROVIDE US MORE INFO ON THE MEDWATCH COMPLAINT. THE CALL WAS TRANSFERRED TO REPORTER (RISK MANAGEMENT DEPT) BUT WE WERE NOT ABLE TO GET A HOLD OF REPORTER. WE THEN TRANSFERRED BACK TO RECEPTIONIST TO SEE IF ANYONE ELSE COULD HELP ON THIS. THE CALL WAS THEN TRANSFERRED TO (PURCHASING DEPT) BUT SHE WAS NOT THE RIGHT PERSON TO TALK TO. THE CALL WAS THEN TRANSFERRED BACK TO OPERATOR. THE OPERATOR WAS UNABLE TO DIRECT OUR CALL AND SAID, WE NEED TO HAVE SPECIFIC DEPT THAT WE NEED TO SPEAK TO SO THAT HE COULD DIRECT THE CALL TO THE DESIGNATED DEPT. THE OPERATOR SUGGESTED TO US TO SPEAK TO THE PERSON WHO WORKS IN TECH MANAGEMENT DEPT, AND HE SAID HE IS NOT THE ONE WHO DEALS WITH THE ISSUE. TECH MGMT DEPT SAID, WE MAY WANT TO TALK WITH KIM WEATHERING WHO IS SUPERVISOR. WE LEFT A MESSAGE TO ANOTHER PERSON REGARDING TO THE MEDWATCH REPORT. REPORTER CALLED BACK AT 4:30 PM AND TOLD US THAT SHE DOES NOT HAVE ANY EXTRA INFO THAT SHE CAN PROVIDE US. SHE ALSO SAID THAT SHE DOES NOT HAVE THE TIME TO DO THE EXTRA WORK TO FIND MORE INFO FOR US. QA MANAGER THEN EXPLAINED TO REPORTER THAT WE WOULD LIKE TO DO AN INVESTIGATION ON THE MALFUNCTION UNIT AND ASKED FOR ANY SERVICE REPORT, AND TO SEE IF KAREN CAN RETURN THE UNIT BACK TO US FOR EVAL. REPORTER SAID THE UNIT IS ALREADY LOCKED UP AND CANNOT BE RETURNED, AND THIS IS THEIR STANDARD PROCEDURE THAT THEY FOLLOW.