BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAQUET HCU40 DEVICE

    MDR report key: 3955785 · Received April 3, 2014

    Report

    Report Number
    8010762-2014-00170
    Event Type
    Injury
    Date Received
    April 3, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K130300
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE, THE PATIENT TEMPERATURE COULD NOT BE INCREASED AND REMAINED AT 30 DEGREES. THE UNIT WAS RESET AND A SELF-TEST FAILURE WAS REPORTED (YELLOW WARNING ALARM SIGNAL REPORTED FOR HEATER PATIENT CIRCUIT AND SAFETY SHUTDOWN PATIENT CIRCUIT). THE UNIT WAS EXCHANGED FOR AN OLDER HEMOTHERM UNIT. NO PATIENT INJURY WAS REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203200 MAQUET HCU40 DEVICE HCU40 HIGH VOLTAGE DWC MAQUET CARDIOPULMONARY AG 70104.4054 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention