BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE INTRA-AORTIC BALLOON

    MDR report key: 2283 · Received January 15, 1993

    Report

    Report Number
    2283
    Event Type
    Malfunction
    Date Received
    January 15, 1993
    Date of Event
    November 21, 1992
    Report Date
    December 8, 1992
    Manufacturer
    DATASCOPE
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    NOVEMBER 21, 1992 AT 2000 HOURS, INTRA-AORTIC BALLOON CATHETER ALARM SOUNDED. TUBING CHECKED AND BLOOD WAS NOTED IN CATHETER AND A SMALL AMOUNT IN TUBING. IABP SHUT OFF, CARDIAC SURGEON IMMEDIATELY AVAILABLE AND REMOVED BALLOON. PATIENT HEMODYNAMICALLY STABLE AND A NEW BALLOON INSERTION WAS NOT INDICATED. PATIENT WAS POSTOPERATIVE CABG X2 AND ANEURYSMECTOMY ON 11/20/92. THERE WAS NO PATIENT INJURYDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULTS OF EVALUATION: TELEMETRY FAILURE, NONE OR UNKNOWN, INHERENT RISK OF PROCEDURE, BALLOON. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE INTRA-AORTIC BALLOON Implant INTRA-AORTIC BALLOON DSP DATASCOPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other