CARDIOSAVE HYBRID, TYPE I PLUG

Additional Manufacturer Narrative

**UDI RELATED DATA QUALITY UPDATES ONLY** PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID (D1, D2, D3, D4, G4, H4, H5).

Description of Event or Problem

IT WAS REPORTED THAT DURING USE ON A PATIENT, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) UNIT REQUIRED MAINTENANCE AND COMMUNICATION FAILURE. THE UNIT AS REPLACED WITH ANOTHER DEVICE. THERE WAS NO DAMAGE CAUSED TO THE PATIENT.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

UPDATED FIELDS: E1(INITIAL REPORTER, EVENT SITE POSTAL CODE- 100020), H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS). A GETINGE FSE WAS DISPATCHED TO EVALUATE THE UNIT. THE CUSTOMER'S WARRANTY DEVICE REQUIRED MAINTENANCE AND COMMUNICATION FAILURE. THE DEVICE AND FAULT CODE RECORDS WERE CHECKED ON-SITE AT THE HOSPITAL TO CONFIRM THE FAULT REPORTED BY THE CUSTOMER. NO FAULT WAS FOUND. THE DEVICE WAS CLEANED OF DUST. THE DEVICE PASSED ALL FACTORY-SPECIFIED PERFORMANCE AND SAFETY INDICATOR TESTS. THE DEVICE HAS BEEN DELIVERED TO THE CUSTOMER AND CAN BE USED CLINICALLY.