BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 40 CC FOS

    MDR report key: 2150570 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00206
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT OCCURRED IN THE CATH LAB. DURING PRODUCT PREPARATION OF THE (B)(4), THE FIBEROPTIX SENSOR (FOS) SLIDE WAS CONNECTED TO THE PUMP AND THE FOS WOULD NOT ZERO OR BE RECOGNIZED. IT WAS ATTEMPTED TO DISCONNECT AND RECONNECT MULTIPLE TIMES WITH NO CHANGE IN STATUS. ANOTHER PUMP WAS ALSO TRIED WITH NO SUCCESS. AS A RESULT, THE IAB WAS NOT USED. REFERENCE MDR #1219856-2011-00207 FOR THE SECOND EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 40 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC. KS1039500

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK