BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE

    MDR report key: 3145124 · Received May 30, 2013

    Report

    Report Number
    2249723-2013-00050
    Event Type
    Malfunction
    Date Received
    May 30, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 12, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY REPRESENTATIVE REPLACED THE VIDEO GENERATOR BOARD (PART NUMBER 0670-00-0781) AND THE INTERNAL CABLE CONNECTING THE BACK-PLANE PCB TO THE MONITOR'S COILED CABLE (PART NUMBER 0012-00-1796). IN UNRELATED REPAIRS, HE ALSO REPLACED THE FILL MANIFOLD ASSEMBLY (PART NUMBER 0997-00-0565). THE IABP WAS TESTED TO FACTORY SPECIFICATION. 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 PATIENT, THE IABP BECAME EXTREMELY LOUD AND NUMBERS WERE MISSING ON THE DISPLAY. THE IABP WAS SHUT OFF AND THEN TURNED BACK ON. IT WORKED FINE UNTIL A DAY LATER WHEN IT BECAME LOUD AGAIN AND THE DISPLAY SHUT OFF. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238485 CARDIOSAVE INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CARDIOSAVE HYBRID NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI