BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATASCOPE PERCOR STAT DL 9.5 FR 40CC

    MDR report key: 72 · Received March 18, 1992

    Report

    Report Number
    72
    Event Type
    Malfunction
    Date Received
    March 18, 1992
    Date of Event
    February 23, 1992
    Report Date
    February 24, 1992
    Manufacturer
    DATASCOPE
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    IAB INSERTED ON 2/19/92 @ 0900. ON 2/23/92 @ 0915. IAB TUBING & SAFETY CHAMBER NOTED TO HAVE BLOOD IN IT. IAB D/CHEMODYNAMICS/VITAL SIGNS UNCHANGED. IAB REMOVED FROM SERVICE. PT. REMAINED OFF IABDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA AORTIC BALLOON CATHETER DSP DATASCOPE 9.5 FR 40CC SHEATLESS VERSION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other