BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 3554643 · Received November 27, 2013

    Report

    Report Number
    2249723-2013-00182
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    October 12, 2013
    Report Date
    October 14, 2013
    Manufacturer
    DATASCOPE CORP
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REP REPLACED THE HELIUM PRESSURE REGULATOR (PART NUMBER: 0103-00-0637). THE IABP WAS TESTED TO FACTORY SPEC. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PT, THE IABP SHUT DOWN TWICE BECAUSE THE HELIUM SENSOR INDICATED THAT THERE WAS NO HELIUM, EVEN THOUGH HELIUM WAS PRESENT. THE PT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620040 CARDIOSAVE HYBRID TYPE B PLUG INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP CARDIOSAVE NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR