BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAT DL 9.5 FR. 40 CC. IAB

    MDR report key: 132612 · Received November 8, 1997

    Report

    Report Number
    2248146-1997-01177
    Event Type
    Malfunction
    Date Received
    November 8, 1997
    Report Date
    October 22, 1997
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE PRODUCT WAS NOT RETURNED TO DATASCOPE FOR EVAL INSPITE OF NUMEROUS ATTEMPTS TO CONTACT THE CUSTOMER FOR THE RETURN OF THE PRODUCT.

    Description of Event or Problem · 1

    THE IAB LEAKED AND THE IAB WAS REMOVED. ANOTHER IAB WAS INSERTED. MULTIPLE EVENT TO CUSTOMER COMPLAINT NUMBERS 97-01206, 97-01208, 97-01210. INSPITE OF SEVERAL CALLS TO THE FACILITY, THE IAB WAS NEVER RETURNED TO DATASCOPE FOR EVAL. [EVENT COMPLICATIONS]: NONE FROM THE EVENT-REPORTED 10/22/97. [PT'S CURRENT STATUS]: UNK-RPT'D 10/22/97.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAT DL 9.5 FR. 40 CC. IAB INTRA-AORTIC BALLOON CATHETER DSP DATASCOPE CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN