BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW CONSOLE

    MDR report key: 4450538 · Received January 21, 2015

    Report

    Report Number
    3008355164-2015-00006
    Event Type
    Injury
    Date Received
    January 21, 2015
    Date of Event
    December 29, 2014
    Report Date
    December 29, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    KFM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNIT GAVE A BATTERY OVERTEMP ALARM WHILE IN USE AND THE EMERGENCY DRIVE/HAND-CRANKING WAS REQUIRED UNTIL THE UNIT COOLED DOWN. THE UNIT WAS NOT ABLE TO BE SWITCHED DURING THE TIME OF THE ALARM. THE NEXT DAY, (B)(6) 2014, THE UNIT SHUT DOWN AGAIN GIVING A BATTERY OVERTEMP ALARM AND REQUIRING HAND-CRANKING UNTIL THE UNIT COOLED DOWN. (B)(4). THIS EVENT IS RELATED TO: MEDWATCH REPORT # 8010762-2015-00007 AND 3008355164-2015-00005. MFR # 8010762-2015-00008.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50667 ROTAFLOW CONSOLE ROTAFLOW CONSOLTE KFM MAQUET CARDIOPULMONARY AG 70105.1712

    Patients

    Seq Age Sex Outcome Treatment
    1 21 DA Required Intervention