BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET HCU30 DEVICE

    MDR report key: 3841115 · Received May 16, 2014

    Report

    Report Number
    8010762-2014-00205
    Event Type
    Injury
    Date Received
    May 16, 2014
    Report Date
    April 18, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K130300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A MAQUET FIELD SERVICE TECHNICIAN INVESTIGATED THE DEVICE AND FOUND A SCORCHED R56 THERMISTOR ON THE POWER SUPPLY BOARD. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HCU30 DEVICE DID NOT COOL THE TANK WATER. THE DEVICE WAS SWAPPED FOR ANOTHER ONE DURING THE OPERATION. NO PT INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293342 MAQUET HCU30 DEVICE HCU30 200V-240V DWC MAQUET CARDIOPULMONARY AG 70103.4642

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention