BEUDAMED
    FDA Adverse Event Death Summary report: N

    DINAMAP MPS SELECT MONITOR

    MDR report key: 280427 · Received June 2, 2000

    Report

    Report Number
    1030184-2000-00001
    Event Type
    Death
    Date Received
    June 2, 2000
    Report Date
    June 2, 2000
    Manufacturer
    CRITIKON CO. LLC
    Product Code
    DXN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ER PHYSICIAN ATTENDED AN UNCONSCIOUS PT ADMITTED TO THE ER WITH SUSPECTED INTRA-CRANIAL BLEEDING WHO ALSO HAD A CARDIAC/RESPIRATORY ARREST. PT WAS CONNECTED TO MPS SELECT VITAL SIGNS MONITOR FOR ECG, NO REPORT OF OTHER PARAMETERS MONITORED AT THAT TIME. THE PT WAS BEING RESUSCITATED; INTUBATED AND RESPIRATION ASSISTED WITH AN AMBU BAG. THE MONITOR WAS REPORTED TO HAVE GIVEN A FLAT, SLIGHTLY WAVY ECG WAVEFORM, WHICH LOOKED LIKE ASYSTOLE. THIS WAS NOT AN UNEXPECTED OUTCOME. THE PHYSICIAN MONITORED THE ECG WAVEFORM AND DID NOT LOOK AT HEART RATE ON MONITOR, NOR WAS PHYSICIAN MONITORING BLOOD PRESSURE AT THIS TIME. PHYSICIAN DOES NOT RECALL IF THE MONITOR GAVE AN ALARM. NO INFO WAS PROVIDED CONCERNING WHETHER OTHER VITAL SIGNS WERE MONITORED TO CONFIRM ASYSTOLE. THE PT WAS TREATED WITH EPINEPHRINE. THE PHYSICIAN EXAMINED THE PT FOR BREATH AND HEART SOUNDS AND REPORTED THAT THE PT DID HAVE A PULSE. THE PHYSICIAN BELIEVES THE PULSE MAY HAVE BEEN PRESENT PRIOR TO THE EPINEPHRINE IV. A DIFFERENT MPS SELECT VITAL SIGNS MONITOR WAS CONNECTED TO THE PT AND IT REPORTED A HEART RATE OF 150-160. A BLOOD PRESSURE READING GAVE A 240/140 RESULT. PT WAS THEN GIVEN A NITROGLYCERIN IV TO REDUCE THE BLOOD PRESSURE. PT WAS SOMEWHAT STABILIZED AND SENT FOR A CAT SCAN THAT REVEALED MASSIVE INTRA-CRANIAL BLEEDING. THE PT DIED 3 HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DINAMAP MPS SELECT MONITOR MULTIPARAMETER VITAL SIGNS MONITOR DXN CRITIKON CO. LLC MPS SELECT NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| L