BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE ROLLER PUMP MODULE

    MDR report key: 4562023 · Received February 26, 2015

    Report

    Report Number
    8010762-2015-00118
    Event Type
    Malfunction
    Date Received
    February 26, 2015
    Date of Event
    January 19, 2015
    Report Date
    January 20, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DPW
    PMA / PMN Number
    K943803
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FIELD SAFETY TECHNICIAN HAS BEEN INVESTIGATED AND FOUND FAILURE REPORTED. HE ADDED THE GROUNDING AND NO FURTHER INSTANCES SINCE THEN. THUS THE FAILURE COULD 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

    A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4). BOTH PRODUCTS ARE COMPONENTS OF THE HL20 INTEGRATED PERFUSION SYSTEM CLEARED UNDER 51(K) K943803.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE OF THE RPM 20'S RAN AT FULL SPEED MOMENTARILY. THIS HAPPENED JUST AFTER THE CASE WHILE EMPTYING THE VENT LINES. NO REPORTED PATIENT EFFECT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137331 SINGLE ROLLER PUMP MODULE DPW MAQUET CARDIOPULMONARY AG MCP0.0703309

    Patients

    Seq Age Sex Outcome Treatment
    1 Other