BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAQUET CARDIOPULMONARY AG

    MDR report key: 4914867 · Received July 13, 2015

    Report

    Report Number
    8010762-2015-00800
    Event Type
    Malfunction
    Date Received
    July 13, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 23, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DPW
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING SIMILAR MALFUNCTION, HAVE TESTED. CUSTOMER STATED THE TWIN PUMP WOULD DISPLAY A BELT SLIP MESSAGE ON SCREEN PRIOR TO USE. SERVICE WAS CALLED AND EVALUATED THE TWIN PUMP. RAN SYSTEM AT LOW AND HIGH ROUNDS PER MINUTE WITH TEST TUBING PACK AND NO MESSAGE OR BELT SLIP WAS DISPLAYED. TESTED SYSTEM TO FACTORY SPECIFICATIONS. TESTED OK. THUS FAILURE CANNOT BE CONFIRMED. THE DATA IS ALSO BEING HANDLED THROUGH A DESIGNATED MAQUET CARDIOPULMONARY TRENDING AND APPLICABLE INVESTIGATION PROCESS. DUE TO THIS NO FURTHER INVESTIGATION INITIATIONS WILL BE COMPLETED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY IS AWARE OF SIMILAR COMPLAINTS FROM THIS PRODUCT. SIMILAR PRODUCTS, SHOWING SIMILAR MALFUNCTION HAVE TESTED. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED AFTER RECEIVING NEW INFORMATION.

    Description of Event or Problem · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER STATED BELT SLIP ALARM. NO CONSEQUENCES TO THE PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452933 MAQUET CARDIOPULMONARY AG DPW MAQUET CARDIOPULMONARY AG 70103.5075

    Patients

    Seq Age Sex Outcome Treatment
    1