BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSATION PLUS 7.5FR 40CC

    MDR report key: 16014389 · Received December 20, 2022

    Report

    Report Number
    16014389
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    October 21, 2022
    Report Date
    October 28, 2022
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IABP WITH OPTICAL SENSOR FAILURE ALARM, TROUBLESHOOTING UNSUCCESSFUL TO RESOLVE ALARM. GETINGE TECHNICAL SUPPORT NOTIFIED, NO ADDITIONAL TROUBLESHOOTING OPTIONS OR SOLUTIONS PRESENTED. IABP CONTINUES TO RUN NORMALLY. NO PRECIPITATING FACTORS IDENTIFIED PRIOR TO SENSOR FAILURE ALARM. PER GETINGE CLINICAL SUPPORT, THEY WOULD LIKE TO HAVE THIS BALLOON SENT BACK TO COMPANY FOR FURTHER EVALUATION / DIAGNOSTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2701599 SENSATION PLUS 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 30002426540003

    Patients

    Seq Age Sex Outcome Treatment
    1 26280 DA Male