BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 10876384 · Received November 20, 2020

    Report

    Report Number
    2249723-2020-01979
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    October 29, 2020
    Report Date
    December 14, 2020
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, G4, G7, H2, H6(EVALUATION METHOD CODES), H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), BATTERY #1 FOR THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS OBSERVED TO HAVE STARTED OUT WITH 65,460 MWH OF CHARGE, AND AFTER 35 MINUTES, THE IABP UNIT SHUT DOWN. IT WAS OBSERVED THAT WHILE THE IABP UNIT WAS CHARGING, THE BATTERY CHARGE AFTER SHUTDOWN REMAINED A 0 MWH. THE BATTERY CHARGING LED EVENTUALLY TURNED OFF, ALONG WITH THE BATTERY NUMBER INDICATOR 1; THUS; NO LONGER CHARGING BATTERY. THE FSE OBSERVE THAT BATTERY #2 WAS ABLE TO BE CHARGED IN BOTH BAYS WITHOUT ISSUE. HOWEVER, BATTERY #1 WAS UNABLE TO BE CHARGED IN EITHER BAY. IT WAS NOTED THAT THE BATTERIES HAD BEEN INSTALLED IN (B)(6) 2020. THE FSE OBSERVED NOTHING UNUSUAL IN THE IABP LOG FILES. THERE WAS NO PATIENT INVOLVED AND NO ADVERSE EVENT WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE FSE REPLACED THE BATTERIES THEN COMPLETED PM SERVICE INCLUDING 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. THE INITIAL REPORTER NAMED (B)(6), WHICH DIFFERS FROM THAT OF THE EVENT SITE. THE FULL NAME SHOULD READ (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE FIELD SERVICE ENGINEER (FSE), BATTERY #1 FOR THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS OBSERVED TO HAVE STARTED OUT WITH 65,460 MWH OF CHARGE, AND AFTER 35 MINUTES, THE IABP UNIT SHUT DOWN. IT WAS OBSERVED THAT WHILE THE IABP UNIT WAS CHARGING, THE BATTERY CHARGE AFTER SHUTDOWN REMAINED A 0 MWH. THE BATTERY CHARGING LED EVENTUALLY TURNED OFF, ALONG WITH THE BATTERY NUMBER INDICATOR 1; THUS; NO LONGER CHARGING BATTERY. THE FSE OBSERVE THAT BATTERY #2 WAS ABLE TO BE CHARGED IN BOTH BAYS WITHOUT ISSUE. HOWEVER, BATTERY #1 WAS UNABLE TO BE CHARGED IN EITHER BAY. IT WAS NOTED THAT THE BATTERIES HAD BEEN INSTALLED IN APRIL 2020. THE FSE OBSERVED NOTHING UNUSUAL IN THE IABP LOG FILES. THERE WAS NO PATIENT INVOLVED, AND NO ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343974 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