BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOSPHERE

    MDR report key: 19884724 · Received August 1, 2024

    Report

    Report Number
    2015691-2024-05811
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    July 23, 2024
    Report Date
    August 1, 2024
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQE
    PMA / PMN Number
    K163381
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW WAS NOT COMPLETED AS A LOT NUMBER WAS NOT PROVIDED. THE UNIT WILL NOT BE RETURNED AND DIAGNOSTIC LOGS WERE NOT PROVIDED. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT 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. THE FOLLOWING ARE ADDITIONAL PRODUCT CODES FOR THIS DEVICE DQK, QAQ, MUD, DXN, DSB, QMS, FLL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE HEM1 HAD AN INACCURATE TRANSMISSION. THE BEDSIDE MONITOR WAS SHOWING 20 MMHG HIGHER THAN THE ACTUAL BLOOD PRESSURE ON THE HEMOSPHERE. THE REP REZEROED THE HEM1 AND IT TRANSMITTED AND IT MATCHED TO THE BEDSIDE. THERE WILL BE NO PRODUCT RETURN OR LOGS PROVIDED PER THE REP. THIS WAS DURING USE. THERE IS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WERE UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733046 HEMOSPHERE CATHETER, OXIMETER, FIBEROPTIC DQE EDWARDS LIFESCIENCES HEM1

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown