BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HL-20 TWIN PUMP

    MDR report key: 4944755 · Received July 28, 2015

    Report

    Report Number
    8010762-2014-00975
    Event Type
    Malfunction
    Date Received
    July 28, 2015
    Date of Event
    December 19, 2013
    Report Date
    December 19, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DPW
    PMA / PMN Number
    K984338
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE UNIT WAS INVESTIGATED BY A SSU SERVICE TECHNICIAN AND THE OPTICAL TACHOMETER PCB WAS FOUND TO BE DEFECTIVE AND WAS REPLACED. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, AT THE (B)(6) HOSPITAL, (B)(6), IT WAS REPORTED THAT THE TPM 20-330 TWIN ROLLER PUMP MODULE SERIAL NUMBER (B)(4) DISPLAYED A HEAD ERROR ON THE RIGHT SIDE PUMP WHEN POWERED ON. THE DEVICE WAS REMOVED FROM SERVICE AND THE CUSTOMER WAS GIVEN A LOANER UNIT. THE NON-CONFORMITY REPORT INDICATES THAT THE FAILURE OCCURRED PRIOR TO USE ON A PATIENT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490193 HL-20 TWIN PUMP FLOWMETER, BLOOD, CARDIOVASCULAR DPW MAQUET CARDIOPULMONARY AG 70103,5075

    Patients

    Seq Age Sex Outcome Treatment
    1