BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 6961149 · Received October 19, 2017

    Report

    Report Number
    2249723-2017-00661
    Event Type
    Malfunction
    Date Received
    October 19, 2017
    Date of Event
    September 26, 2017
    Report Date
    October 23, 2017
    Manufacturer
    DATASCOPE MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE TERRITORY MANAGER (STM) WAS ABLE TO REPRODUCE THE PROBLEM ALLEGED BY THE CUSTOMER. THE STM DID A TROUBLESHOOT OF THE INTRA-AORTIC BALLOON PUMP (IABP), DISASSEMBLED AND CHECKED FOR ANY VISIBLE DAMAGE OR SALINE SPILL. NO DAMAGE WAS PRESENT. THE STM THEN FOUND THE BACKPLANE TO COIL CABLE WAS THE CAUSE OF THE MALFUNCTION. THE CABLE, BACKPLANE TO COILED CABLE 0012-00-1796 WAS REPLACED. THE IABP WAS THEN REASSEMBLED AND TESTED FOR PROPER OPERATION. THE STM COMPLETED ALL TEST AND CALIBRATIONS PER MANUFACTURE SPECIFICATIONS, UNIT HAS PASSED ALL TEST AND IS NOW READY FOR CLINICAL USE.

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS REVIEWED AND NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUT DOWN WHILE ON A PATIENT. THE CUSTOMER REPORTED THE CARDIOSAVE MADE A LOUD SCREECHY NOISE AND SHUT OFF. IT PUMPED AGAIN AFTER REBOOTING BUT THE PROBLEM REPEATED AFTER AN HOUR. NO PATIENT INJURY, HARM OR ADVERSE EVENT REPORTED. NO OTHER PATIENT INFO AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUT DOWN WHILE ON A PATIENT. THE CUSTOMER REPORTED THE CARDIOSAVE MADE A LOUD SCREECHY NOISE AND SHUT OFF. IT PUMPED AGAIN AFTER REBOOTING BUT THE PROBLEM REPEATED AFTER AN HOUR. NO PATIENT INJURY, HARM OR ADVERSE EVENT REPORTED. NO OTHER PATIENT INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742904 CARDIOSAVE SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1