BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHILEY

    MDR report key: 3831913 · Received March 6, 2014

    Report

    Report Number
    2936999-2014-00219
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Report Date
    February 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    JOH
    PMA / PMN Number
    K962173
    Removal / Correction Number
    Z-2174-2012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS NOT AVAILABLE FOR ANALYSIS AND NO LOT# AVAILABLE. WE ARE UNABLE TO DETERMINE THE CAUSE FOR THIS SPECIFIC EVENT; HOWEVER, THE REPORTED ISSUE IS A KNOWN ISSUE AND A CORRECTIVE AND PREVENTATIVE ACTION WAS PREVIOUSLY INITIATED TO DOCUMENT THE INVESTIGATION EFFORTS RELATED VOLUME LEAKAGE AND/OR DISCONNECTION BETWEEN THE INNER AND OUTER CANNULA FOR THE REPORTED PRODUCT. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES AND COMPLAINT TRENDS ARE REVIEWED MONTHLY TO DETERMINE IF ADDITIONAL ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THERE IS A PATIENT THAT HAS BEEN USING THIS PRODUCT SINCE 1997 AND IN THE LAST FEW MONTHS THE TUBES BECAME LOOSE DURING NIGHT TIME RESULTING IN LOSS OF VENTILATION TO THE PATIENT. THE CUSTOMER REPORTED THAT THE VENTILATOR PROVIDES AN AUDIBLE ALARM WHEN THIS OCCURS. CUSTOMER DID NOT CONFIRM THE NEED FOR REPLACEMENT OF THE TUBE. THE REPORTER STATES NO SAMPLE IS AVAILABLE FOR ANALYSIS AND NO LOT NUMBER. THERE WAS NO INCIDENT DATE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134543 SHILEY FENESTRATED LOW PRESSURE CUFFED TR JOH COVIDIEN 8FEN

    Patients

    Seq Age Sex Outcome Treatment
    1