BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE MONITORING TUBING

    MDR report key: 188242 · Received September 16, 1998

    Report

    Report Number
    2248146-1998-01035
    Event Type
    Malfunction
    Date Received
    September 16, 1998
    Report Date
    September 2, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    EVENT: (CC# 98-01110) THE IAB WAS DEFECTIVE. ON 10/2/98, THE FOLLOWING WAS REPORTED TO DATASCOPE: THE ARTERIAL LINE WAS BAD. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 9/2/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 9/2/98.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESSURE MONITORING TUBING PRESSURE MONITORING TUBING DRS DATASCOPE CORP. 0008-00-0293-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN