BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR

    MDR report key: 3915336 · Received June 9, 2014

    Report

    Report Number
    3915336
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 9, 2014
    Manufacturer
    MAQUET, INC.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US

    Narratives

    Description of Event or Problem · 1

    WAVE FORM CHANGE NOTED WITH BLOOD IN THE TUBING. NO ALARM. IABP CONTINUED TO OPERATE BUT WAS NOT FUNCTIONING CORRECTLY. PATIENT EXPERIENCED CHEST PAIN. IABP PULLED AND PATIENT TAKEN TO CATH LAB. IAB REINSERTED.MANUFACTURER RESPONSE FOR INTRA-AORTIC BALLOON, LINEAR INTRA-AORTIC BALLOON (PER SITE REPORTER).======================NONE AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334233 LINEAR SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP MAQUET, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R NO OTHER THERAPIES| DATASCOPE PUMP