CARDIOSAVE HYBRID, TYPE I PLUG

Description of Event or Problem

N/A

Additional Manufacturer Narrative

UPDATED FIELDS; B4, D9, G3, G6, H2, H3, H4, H6, H11. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE IABP UNIT. THE FSE COULD NOT DUPLICATE THE ISSUE. THE UNIT PASSED ALL SAFETY AND FUNCTIONAL TESTS AND WAS RETURNED TO THE CUSTOMER FOR CLINICAL USE.

Additional Manufacturer Narrative

A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) HAS A SCREEN MALFUNCTION . THE RN CALLED FOR ASSISTANCE THE MONITOR DISPLAY AND TOUCHSCREEN WERE FLASHING RED, WHITE AND BLUE. THE FLASHING SCREEN WAS RESOLVED BY RESTARTING THE CONSOLE. THE RN WAS INSTRUCTED TO LABEL THE CONSOLE WITH ¿DO NOT USE, MONITOR FLASHING RED, WHITE AND BLUE. BIOMED TO INVESTIGATE¿ AND PASS ALONG THE INFORMATION SO THAT THE CONSOLE COULD BE ASSESSED BY BIOMED. THERE WAS NO PATIENT HARM REPORTED.