BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 19715764 · Received July 10, 2024

    Doing adverse event research by hand?

    The Research Assistant searches MAUDE for you, groups reports by failure mode, and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Report

    Report Number
    2015691-2024-05245
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 20, 2024
    Report Date
    August 22, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQK
    UDI-DI
    00690103197006
    PMA / PMN Number
    K163381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS REQUESTED FOR RETURN BUT DID NOT ARRIVE FOR EVALUATION. WITHOUT THE RETURN OF THE PRODUCT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE EVENT. IT IS NOT KNOWN IF SOME PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THE MONTHLY REVIEW. ADDITIONAL PRODUCT CODES, DQE CATHETER, OXIMETER, FIBEROPTIC, QAQ ADJUNCTIVE PREDICTIVE CARDIOVASCULAR INDICATOR, MUD, OXIMETER, TISSUE SATURATION, DXN SYSTEM, MEASUREMENT, BLOOD PRESSURE, NON-INVASIVE, DSB PLETHYSMOGRAPH, IMPEDANCE, QMS. ADJUNCTIVE OPEN LOOP FLUID THERAPY RECOMMENDER, FLL, THERMOMETER, ELECTRONIC, CLINICAL.

    Additional Manufacturer Narrative · 0

    THE HEMOSPHERE HAS BEEN REQUESTED FOR RETURN FOR EVALUATION. IT HAS NOT YET ARRIVED. ONCE IT HAS ARRIVED AND THE PRODUCT EVALUATION RESULTS ARE AVAILABLE A SUPPLEMENTAL REPORT WILL BE SENT WITH THE RESULTS. THE DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND ALL MANUFACTURING INSPECTIONS PASSED WITH NO NON-CONFORMANCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE INACCURATE VALUES THAT DISPLAYED WITH THE HEMOSPHERE INSTRUMENT. THE BLOOD PRESSURE READING WAS DISPLAYING AS 15 TO 20MMHG LOWER THAN WHAT WAS BEING DISPLAYED ON THE PHILIPS BEDSIDE MONITOR. THE PX1800 CABLE COULD NOT BE RULED OUT. THE REPORT FOR THE CABLE WILL BE SENT UNDER A SEPARATE SUBMISSION. THE PRESSURE CABLES THAT WERE BEING USED WERE NEW EDWARDS CABLES. THE HYPOTENSION WAS NOT TREATED FOR HOURS BECAUSE THE BLOOD PRESSURE READINGS TRANSMITTED ONTO THE PHILIPS BEDSIDE MONITOR WERE ACCEPTABLE. CABLES AND PHILIPS BRICKS WERE SWITCHED OUT TO RESOLVE THE ISSUE. PATIENT DEMOGRAPHICS HAVE BEEN REQUESTED AND NOT PROVIDED. THERE WAS NO PATIENT HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359398 HEMOSPHERE HEMOSPHERE ADVANCED MONITOR DQK EDWARDS LIFESCIENCES HEM1 00690103197006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown