BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR 7.5 FR. 25CC IAB

    MDR report key: 9203985 · Received October 17, 2019

    Report

    Report Number
    2248146-2019-00837
    Event Type
    Malfunction
    Date Received
    October 17, 2019
    Date of Event
    September 24, 2019
    Report Date
    October 17, 2019
    Manufacturer
    DATASCOPE CORP. - FAIRFIELD
    Product Code
    DSP
    PMA / PMN Number
    K041281
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: PMA/510(K)#: FROM: K122628. TO: K041281. REFERENCE COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE OF THE INTRA-AORTIC BALLOON (IAB), THE CATHETER APPEARED TO HAVE MOISTURE INSIDE THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    EVENT SITE NAME - (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER SO WE ARE UNABLE TO COMPLETE AN EVALUATION. IF PROVIDED WE WILL SEND A SUPPLEMENTAL REPORT WITH OUR ADDITIONAL FINDINGS. REFERENCE COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE OF THE INTRA-AORTIC BALLOON (IAB), THE CATHETER APPEARED TO HAVE MOISTURE INSIDE THE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995642 LINEAR 7.5 FR. 25CC IAB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - FAIRFIELD 3000074610

    Patients

    Seq Age Sex Outcome Treatment
    1