BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB:7 FR - 30 CC

    MDR report key: 3102299 · Received April 30, 2013

    Report

    Report Number
    1219856-2013-00106
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED WHILE IN THE CARDIOLOGY DEPT DURING USE. THE MD PLACED THE INTRA-AORTIC BALLOON (IAB) IN THE PT ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) AND IT WORKED AT THE BEGINNING OF USE. HOWEVER, THE IAB DID NOT INFLATE PROPERLY DURING USE. AS A RESULT, THE MD REMOVED THE IAB SUCCESSFULLY. A NEW IAB WAS INSERTED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. NO DELAY OR INTERRUPTION IN THERAPY WAS NOTED. THE PT OUTCOME IS NO HARMFUL OUTCOME TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186783 IAB:7 FR - 30 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP