BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3243013 · Received July 18, 2013

    Report

    Report Number
    2936999-2013-00519
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 18, 2013
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PENDING RECEIPT OF SAMPLE FOR ANALYSIS. IF SAMPLE IS RECEIVED, A SUMMARY OR THE INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED: DURING THE PRE-TEST, PRIOR TO USE ON A PATIENT, THE DOCTOR FOUND THE CUFF WOULD NOT DEFLATE COMPLETELY. CUSTOMER CONFIRMS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335423 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1