BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 30 CC FOS

    MDR report key: 1230393 · Received November 7, 2008

    Report

    Report Number
    1219856-2008-00506
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    September 29, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 THAT THE INTRA-AORTIC BALLOON (IAB) WAS USED. A NOTE WAS PUT ON THE IAB STATING "DAMAGED" AND PUT ON THE DESK OF A PERSON WHO WAS ON VACATION. THE PERSON WHO PHONED THE REPORT INTO THE COMPLAINT DEPARTMENT WILL ASK THE DEPARTMENT INVOLVED TO GIVE MORE DETAILS. PER THE HOSP, THE IAB WOULD NOT INFLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK