BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HCU 30 BASE UNIT 200-240

    MDR report key: 4627452 · Received March 23, 2015

    Report

    Report Number
    3008355164-2015-00049
    Event Type
    Injury
    Date Received
    March 23, 2015
    Date of Event
    February 18, 2015
    Report Date
    February 23, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRYING TO WARM THE PATIENT SIDE, THE UNIT WOULD SHUT DOWN. THE UNIT WAS TAKEN OUT OF SERVICE AND REPLACED WITH ANOTHER ONE. NO REPORTED PATIENT EFFECT. (B)(4). MFR REPORT#: 8010762-2015-00295.

    Description of Event or Problem · 1

    MFR REF#: 8010762-2015-00295.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193143 HCU 30 BASE UNIT 200-240 HCU 30 BASE UNIT 200-240 V DWC MAQUET CARDIOPULMONARY AG 70102-8718

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention