BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 48491 · Received September 20, 1996

    Report

    Report Number
    2242850-1996-00081
    Event Type
    Malfunction
    Date Received
    September 20, 1996
    Report Date
    August 29, 1996
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE LABEL CODE FOR F10. POSITION 1: 1738. EVALUATION: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE ITEM WAS DISCARDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    ON 11/12/96, DATASCOPE WAS NOTIFIED THAT THE IAB WAS PROBABLY DISCARDED BY THE FACILITY AND WOULD NOT BE RETURNED TO DATASCOPE FOR EVALUATION. ON 2/11/97, THE FOLLOWING WAS REPORTED TO DATASCOPE. THE IAB PUMPED FOR THREE DAYS. EVENT COMPLICATIONS: UNK - REPORTED 8/29/96; NONE - REPORTED 2/11/97. PATIENT'S CURRENT STATUS: DISCHARGED - RPT'D 2/11/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON CATHETER INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN