BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET ADVANCED

    MDR report key: 7533170 · Received May 22, 2018

    Report

    Report Number
    8010762-2018-00172
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    April 24, 2018
    Report Date
    October 17, 2018
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DWE
    PMA / PMN Number
    K130300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. (B)(4). (B)(6).

    Additional Manufacturer Narrative · 0

    AFTER SEVERAL REQUESTS NO INFORMATION HAS BEEN RECEIVED ABOUT THIS COMPLAINT. THE COMPLAINT INITIATOR ASSUME THAT THE PARTS HAVE BEEN SCRAPPED AND NO INVESTIGATION COULD BE PERFORMED. THEREFORE THIS COMPLAINT WILL BE CLOSED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. MAQUET MEDICAL SYSTEMS,USA (IMPORTER) SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31, 76437 RASTATT, GERMANY. A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. REFERENCE EXEMPTION # E2018002. IMPORTER: MAQUET MEDICAL SYSTEMS USA (B)(4). CONTACT PERSON: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE QUADROX HAD ABNORMAL INTERNAL PRESSURE READING. (B)(4).

    Description of Event or Problem · 0

    REF.: (B)(4). CUSTOMER REF.: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377483 HLS SET ADVANCED TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY AG 70118754

    Patients

    Seq Age Sex Outcome Treatment
    1