BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTA-FLOW CONTROL UNIT

    MDR report key: 724554 · Received June 9, 2006

    Report

    Report Number
    8010042-2006-00043
    Event Type
    Malfunction
    Date Received
    June 9, 2006
    Date of Event
    October 25, 2006
    Report Date
    October 30, 2005
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    DWA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET INC. SUBMITTS THIS REPORT ON BEHALF OF THE DEVICE MANUFACTURING FACILITY MAQUET CRITICAL CARE, AB SOLNA, SWEDEN. MAQUET CRITICAL CARE AB PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    WHILE PT WAS ON BYPASS, PUMP RAN FOR 25 MINUTES AND THEN COMPLETELY SHUT DOWN. CUSTOMER STATES THAT THERE WERE NO ALARMS AND NO INDICATION THAT PUMP WAS ON BATTERY POWER. AFTER PUMP FAILURE, PERFUSIONIST USED THE EMERGENCY HAND PUMP FOR 15 MINUTES BEFORE A SECOND BACK-UP PUMP COULD BE INSTALLED. NO PT INJURY HAS OCCURRED. REFERENCE NUMBER: LSS-V05221.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTA-FLOW CONTROL UNIT NI DWA MAQUET CRITICAL CARE AB 0702697 E4.01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR