BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET HCU30 DEVICE

    MDR report key: 3871559 · Received April 16, 2014

    Report

    Report Number
    8010762-2014-00186
    Event Type
    Malfunction
    Date Received
    April 16, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 21, 2014
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWC
    PMA / PMN Number
    K031544
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDED PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. A MAQUET FIELD SERVICE TECH REPLACED THE SHUNT, STOP AND RETURN VALVES. THE PCB COOLING FAN, LEAKING FEMALE RECTUS FITTING AND BROKEN TANK DOOR HINGE WERE ALSO REPLACED. A COMPLETE PREVENTATIVE MAINTENANCE WITH FULL CALIBRATION, FUNCTIONAL TESTING AND SAFETY CHECK TO FACTORY SPECS WAS SUCCESSFULLY EXECUTED. THE UNIT WAS RETURNED TO SERVICE. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE PREVENTATIVE MAINTENANCE PERFORMED BY A MAQUET SERVICE TECHNICIAN, A LEAKING PT FEMALE RECTUS FITTING WAS FOUND IN ADDITION TO A NON FUNCTIONING ELECTRONICS FAN AND BROKEN TANK COVER CLIP. THE OPERATION OF THE UNIT WAS NOT EFFECTED BY THESE FINDINGS. NO PT INVOLVEMENT. REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233541 MAQUET HCU30 DEVICE HCU30 200V-240V DWC MAQUET CARDIOPULMONARY AG 70102.8718 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA