BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 9648675 · Received January 30, 2020

    Report

    Report Number
    2249723-2020-00152
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 7, 2020
    Report Date
    January 29, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTION DEVICE HISTORY RECORD (DHR) FOR THIS INTRA-AORTIC BALLOON PUMP (IABP) WAS NOT REQUIRED TO BE REVIEWED AS PER COMPANY STANDARD OPERATING PROCEDURE SINCE THE DEVICE MANUFACTURE DATE IS GREATER THAN ONE YEAR FROM THE EVENT DATE. THE STM DETERMINED THE CARDIOSAVE WILL BOOT UP WITH BATTERY POWER ONLY. THE POWER SUPPLY AND POWER SUPPLY MONITOR BOARD WERE REPLACED. THE STM COMPLETED ALL SAFETY, FUNCTIONALITY, AND CALIBRATION CHECKS AND ALL TESTS PASSED TO FACTORY SPECIFICATIONS. THE IABP UNIT WAS CLEARED FOR CLINICAL USE AND RELEASED TO THE CUSTOMER.

    Description of Event or Problem · 1

    DURING A ROUTINE CHECK ON THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP), IT WAS REPORTED THAT THE BATTERIES WERE NOT CHARGING AND 120VAC POWER WAS NOT SUPPLIED TO THE UNIT. THE IABP WILL BOOT UP WITH BATTERY POWER ONLY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112018 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1