BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS PARKER MEDICAL ENDOTRACHEAL TUBES

    MDR report key: 7674235 · Received July 10, 2018

    Report

    Report Number
    3000219639-2018-00006
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    June 6, 2018
    Report Date
    July 10, 2018
    Manufacturer
    SALTER LABS
    Product Code
    BTR
    UDI-DI
    00607411959288
    PMA / PMN Number
    K042683
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THIS INFORMATION, THERE WAS A DEVICE MALFUNCTION. PHOTOS PROVIDED SHOW CUFF FAILURE. PATIENT EXPERIENCED RESPIRATORY INSUFFICIENCY WITH NO OTHER INJURY REPORTED. REFERENCE USER FACILITY REPORT 250965414-2018-001.

    Description of Event or Problem · 1

    PATIENT UNDERWENT SURGERY AND SUBSEQUENTLY DEVELOPED RESPIRATORY INSUFFICIENCY. CT SCAN REVEALED PNEUMOMEDIASTINUM. PATIENT WAS TRANSFERRED FOR FURTHER EVALUATION. NO OTHER INJURY IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517744 SALTER LABS PARKER MEDICAL ENDOTRACHEAL TUBES ENDOTRACHEAL TUBES BTR SALTER LABS H-PFST-75 1708ST1400L 00607411959288

    Patients

    Seq Age Sex Outcome Treatment
    1