BEUDAMED
    FDA Adverse Event Death Summary report: N

    QUANTUM WORKSTATION 12.1" ELITE

    MDR report key: 22564806 · Received July 22, 2025

    Report

    Report Number
    3006073153-2025-00174
    Event Type
    Death
    Date Received
    July 22, 2025
    Date of Event
    June 15, 2025
    Report Date
    July 21, 2025
    Manufacturer
    SPECTRUM MEDICAL LTD
    Product Code
    DRY
    UDI-DI
    05060434422309
    PMA / PMN Number
    K202557
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION CONFIRMED THE ADVERSE EVENT OCCURRED AS THE USER DESCRIBED; HOWEVER, THERE WAS NO EVIDENCE OF A PROBLEM WITH THE QUANTUM SYSTEM THAT WOULD HAVE RESULTED IN SUCH EVENT. IT WAS CONCLUDED THAT THE QUANTUM SYSTEM WORKED AS INTENDED AND THE ADVERSE EVENT OCCURRED DUE TO EXTERNAL FACTORS FROM THE QUANTUM SYSTEM.

    Description of Event or Problem · 0

    ADVERSE EVENT OCCURRED THAT RESULTED IN PATIENT DEATH WHILE PATIENT WAS CONNECTED TO THE MEDICAL DEVICE. USER REPORTED THAT BLOOD FLOW WAS UNABLE TO BE RE-ESTABLISHED FOLLOWING CPR AND PATIENT EXPERIENCED HEMORRHAGE BENEATH THE HEART. THE INVESTIGATION DETERMINED THAT THE DEVICE DID NOT MALFUNCTION DURING USE AND WAS OPERATING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779681 QUANTUM WORKSTATION 12.1" ELITE MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS DRY SPECTRUM MEDICAL LTD QWS12E 05060434422309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death