BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACAT 1 IAB PUMP ASSEMBLY

    MDR report key: 1172868 · Received September 19, 2008

    Report

    Report Number
    1219856-2008-00440
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K965209
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED, IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT REGARDLESS OF THE MODE OF "PATTERN TRIGGER", THE ALARM "ECG DETECTED DURING INTERNAL TRIGGER" RANG. AFTER THE EVENT, THE PUMP WAS EXCHANGED TO ANOTHER PUMP (ACAT1). THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACAT 1 IAB PUMP ASSEMBLY INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK