BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DATASCOPE

    MDR report key: 3921 · Received February 11, 1993

    Report

    Report Number
    3921
    Event Type
    Injury
    Date Received
    February 11, 1993
    Date of Event
    September 11, 1992
    Report Date
    September 15, 1992
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    KRK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    CONSECUTIVE BLOOD PRESSURE READINGS WERE IDENTICAL AT 129/73. MANUAL CHECK OF BLOOD PRESSURE OBTAINED AND WAS 54/30. PATIENT REQUIRED ADMINISTRATION OF EPHEDRINE AND INTRAVENOUS FLUIDS TO RESTORE BLOOD PRESSURE TO ACCESTABLE LEVEL. MALFUNCTION COULD NOT BE DUPLICATED BY HOSPITAL BIO-MEDICAL TECHNICIAN UPON EVALUATION AFTER EVENT. UNIT RETURNED TO MANUFACTURER TO EVALUATE AND SERVICE IF NECESSARYDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-FEB-92. SERVICE PROVIDED BY: USER FACILITY BIOMEDICAL/BIOENGINEERING DEPARTMENT. SERVICE RECORDS AVAILABLE.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, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. 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 VITAL SIGN MONITOR KRK DATASCOPE CORPORATION 3000

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other