BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURGE CARDIOVASCULAR

    MDR report key: 17694446 · Received September 6, 2023

    Report

    Report Number
    3017540-2023-00004
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 6, 2023
    Manufacturer
    MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR
    Product Code
    DWF
    UDI-DI
    00817278010354
    PMA / PMN Number
    K964200
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTED HIGH LINE PRESSURE IN MULITPLE PERFUSION SET. NO INJURY/DEATH WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455149 SURGE CARDIOVASCULAR MULTIPLE PERFUSION SET W VENT DWF MED MICHIGAN HOLDINGS LLC / SURGE CARDIOVASCULAR PER-1401S 06667-041023 00817278010354

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown