BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SOFT SEAL

    MDR report key: 3031258 · Received March 5, 2013

    Report

    Report Number
    2183502-2013-00062
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 9, 2013
    Report Date
    March 4, 2013
    Manufacturer
    SMITHS MEDICAL MD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER HAS NOT YET RETURNED THE DEVICE TO THE MFR FOR DEVICE EVAL. WHEN AND IF THE DEVICE BECOMES AVAILABLE AND IS RETURNED AND EVALUATED THE MFR WILL FILE A FOLLOW-UP REPORT DETAILING THE RESULTS OF THE EVAL.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT ALLEGES THAT THE CUFF DEFLATED AFTER AN UNK AMOUNT OF TIME IN USE. REPLACEMENT AS REQUIRED. NO INCIDENT RELATED MEDICAL SEQUELAE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94727 PORTEX SOFT SEAL ENDOTRACHEAL TUBE, SINGLE-USE JOH SMITHS MEDICAL MD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK