CARDIOSAVE HYBRID, TYPE B PLUG

Description of Event or Problem

It was reported by customer that during a routine check the CARDIOSAVE Intra-Aortic Balloon Pump (IABP) malfunctioned. Helium leak has been reported. There was no patient involvement reported. No harm reported. No fault logs available from the provided date of event. The FSE was dispatched to evaluate the unit. It was reported that FSE was able to reproduce the customer's stated issue. It was found that the O-ring on the rear of the rescue unit was pinched/damaged. Replaced the O-ring. Functional tested without any further issues. Cardiosave IABP services completed. Safety, Calibration, and functionality checks to factory specifications.

Additional Manufacturer Narrative

Upon completion of the investigation into this event, a follow up report will be submitted.