BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 10513581 · Received September 10, 2020

    Report

    Report Number
    2249723-2020-01458
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Date of Event
    August 17, 2020
    Report Date
    October 29, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FLIGHT TRANSPORT, BATTERY 2 OF THE CARDIOSAVE (INTRA-AORTIC BALLOON PUMP) QUICKLY BECAME DISCHARGED DESPITE THE FLIGHT CREW CHARGING THE UNIT OVERNIGHT. THERE WAS NO PATIENT INJURY AND NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    A GETINGE SERVICE TERRITORY MANAGER (STM) EVALUATED THE UNIT AND NOTICED BATTERY 2 IN SLOT 1 WITH TWO LEDS OF CHARGE AND CHARGING. UPON FURTHER EXAMINATION, THE STM DISCOVERED BATTERY 1 AT 1450 MWH AT 1120 HOURS WITH ONE LED OF CHARGE AND IT STOPPED CHARGING AT 20740 MWH AT 1148 HOURS WITH FOUR LEDS OF CHARGE WHICH VALIDATED THE CUSTOMER'S ISSUE. THE STM THE NOTED THAT THE BATTERY LED ON THE BACK OF THE CONSOLE WILL SHOW SOLID ONLY WHEN BATTERY 2 IS PULLED FROM THE CONSOLE. SLOT 1 AND 2 WERE PROPERLY CHARGED WHICH CONFIRMED THAT BATTERY 2 WAS THE ISSUE. BATTERY 1 DID NOT MEET THE RUNTIME SPECIFICATIONS WHEN TESTED, BUT BATTERY 1 HELD A CHARGE PER SPECIFICATIONS. THE STM REPLACED BOTH BATTERIES. THE IABP WAS THEN FUNCTIONAL TESTED WITHOUT ANY FURTHER FAILURES WITH ALL SAFETY, CALIBRATION, AND FUNCTIONALITY CHECKS TO FACTORY SPECIFICATIONS. THE IABP WAS RELEASED TO CUSTOMER AND CLEARED FOR CLINICAL USE. COMPLETE EVENT SITE POSTAL CODE: (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FLIGHT TRANSPORT, BATTERY 2 OF THE CARDIOSAVE (INTRA-AORTIC BALLOON PUMP) QUICKLY BECAME DISCHARGED DESPITE THE FLIGHT CREW CHARGING THE UNIT OVERNIGHT. THERE WAS NO PATIENT INJURY AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980704 CARDIOSAVE HYBRID TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH N/A N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR