BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS EXTENSION SET

    MDR report key: 2981136 · Received February 5, 2013

    Report

    Report Number
    9616066-2013-00077
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    January 7, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K790108
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN REC'D. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THEY HAVE FOUND A FILTER LEAKING THROUGH THE AIR VENT HOLE. THERE WAS NOT REPORT OF PT HARM OR MEDICAL INTERVENTION REQUIRED. ALTHOUGH REQUESTED, NO ADD'L EVENT OR PT INFO PROVIDED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47425 ALARIS EXTENSION SET FPA CAREFUSION CORPORATION 10011865 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK