BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADROX-I NEO. MIT RESERVOIR

    MDR report key: 4706435 · Received April 16, 2015

    Report

    Report Number
    8010762-2015-00378
    Event Type
    Malfunction
    Date Received
    April 16, 2015
    Date of Event
    February 14, 2015
    Report Date
    March 17, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTN
    PMA / PMN Number
    K102464
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MAQUET CARDIOPULMONARY RECEIVED THE PROVIDED COMPLAINT DESCRIPTION AND ADDITIONALLY A PICTURE OF THE PRODUCT IN QUESTION. HOWEVER, THE DAMAGE VISABLE ON THE PICTURE IS NOT CONCURRING WITH THE PROVIDED INFO. ADDITIONAL INFO IS REQUESTED. A SUPPLEMENTAL REPORT WILL BE PROVIDED IF NEW INFO BECOMES AVAILABLE. ADDITIONAL INFO: THE PRODUCT MENTIONED IS NOT DISTRIBUTED TO THE US, BUT THE PRODUCT WITH CONTRIBUTING DESIGN FUNCTION TO THE AFFECTED COMPONENT (QU ADROX-I NEONATAL) IS REGISTERED UNDER 510 (K): K102464.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERFUSIONIST FOUND THE DE-AIRING VALVE BROKEN JUST AFTER HE FINISHED PRIMING. THERE WAS NO INTENSE KNOCK ON IT. AND HE STOPPED AND EXCHANGED. NO CONSEQUENCES TO THE PT WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256006 QUADROX-I NEO. MIT RESERVOIR DTN MAQUET CARDIOPULMONARY AG 70105.0109 92125116

    Patients

    Seq Age Sex Outcome Treatment
    1