BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE JAPANESE

    MDR report key: 1052557 · Received May 22, 2008

    Report

    Report Number
    1219856-2008-00248
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 27, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP WILL NOT BE RETURNED FOR EVAL. FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2008 WHILE IN THE CATH LAB, THE INTRA-AORTIC BALLOON (IAB) WAS PREPPED PER INSTRUCTION. THE MD INSERTED THE SHEATH VIA THE LEFT FEMORAL ARTERY. ON THREE DAYS LATER, THE PUMP ALARMED "FOS OUT OF RANGE" AND THE CATHETER "DIDN'T GET THE FOS READING." AS A RESULT, THE PUMP WAS EXCHANGED. A REQUEST FOR MORE INFO REGARDING THE PUMP HAS BEEN MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 WAVE JAPANESE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK