BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE B PLUG

    MDR report key: 3743641 · Received January 30, 2014

    Report

    Report Number
    2249723-2013-00221
    Event Type
    Malfunction
    Date Received
    January 30, 2014
    Date of Event
    November 22, 2013
    Report Date
    November 22, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR THE IABP HAS BEEN REVIEWED. THERE ARE NO NONCONFORMANCES NOTED IN THE DHR RELATED TO THE REPORTED EVENT. THE COMPANY REPRESENTATIVE REPLACED THE FRONT END BOARD (PART NUMBER 0670-00-0769). THE BOARD WAS RETURNED TO THE MANUFACTURING FACILITY, WHERE THE FAILURE WAS CONFIRMED. IT WAS SUBSEQUENTLY RETURNED TO THE SUPPLIER FOR EVALUATION. IN AN UNRELATED REPAIR, HE VERIFIED THE SCROLL COMPRESSOR FAILURE (PART NUMBER 0119-00-0179), WHICH WAS ALSO REPLACED DUE TO AN INABILITY TO CALIBRATE THE PRESSURE TRANSDUCER. THE SCROLL COMPRESSOR HAS BEEN RETURNED TO THE VENDOR FOR FAILURE ANALYSIS. THE SYSTEM WAS TESTED TO FACTORY SPECIFICATIONS. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT PRIOR TO USE ON A PT, THE IABP GENERATED AN ERROR CODE 107 (ANALOG TO DIGITAL CONVERTER OUT OF SPECIFICATION). ANOTHER IABP WAS USED TO INITIATE THERAPY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66524 CARDIOSAVE HYBRID TYPE B PLUG INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE NA

    Patients

    Seq Age Sex Outcome Treatment
    1