BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOPHYS PSAS SYSTEM

    MDR report key: 8807315 · Received July 18, 2019

    Report

    Report Number
    MW5088229
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    July 8, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ENDOPHYS HOLDINGS, LLC
    Product Code
    DSK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ENDOPHYS PSAS SHEATH STOPPED RECORDING BLOOD PRESSURES DURING PROCEDURE AND PT'S BLOOD PRESSURE WAS DROPPING WHICH COULD HAVE CAUSED A SERIOUS INJURY AND / OR DEATH. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599318 ENDOPHYS PSAS SYSTEM COMPUTER, BLOOD PRESSURE - ENDOPHYS BLOOD PRESSURE MONITOR DSK ENDOPHYS HOLDINGS, LLC BPM-20-SC
    599322 ENDOPHYS PSAS SYSTEM INTRODUCER, CATHETER-ENDOPHYS SENSING SHEATH KIT DYB ENDOPHYS HOLDINGS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 165 YR Required Intervention