BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 167234 · Received May 8, 1998

    Report

    Report Number
    2248146-1998-00504
    Event Type
    Malfunction
    Date Received
    May 8, 1998
    Date of Event
    March 27, 1998
    Report Date
    April 30, 1998
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE PRODUCT WAS NOT RETURNED OR RELEASED TO DATASCOPE FOR EVALUATION. THIS FOLLOW-UP MDR WAS MAILED TO THE FDA ON 10/13/98.

    Description of Event or Problem · 1

    EVENT: (CC# 98-00534) THE "GAS LOSS" ALARMS SOUNDED FROM THE PUMP. THE IAB WAS NOT INFLATING PROPERLY. THE PUMP WAS CHANGED BUT THE IAB STILL DID NOT INFLATE PROPERLY. THE IAB WAS REMOVED AND A SECOND IAB WAS INSERTED. NO IAB WAS EVER RETURNED TO DATASCOPE FOR EVALUATION. [EVENT COMPLICATIONS]: UNKNOWN - REPORTED 4/30/98. [PATIENT'S CURRENT STATUS]: UNK - RPT'D 4/30/98.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN