BEUDAMED
    FDA Adverse Event Other Summary report: N

    NA

    MDR report key: 3690750 · Received March 18, 2014

    Report

    Report Number
    2028807-2014-00001
    Event Type
    Other
    Date Received
    March 18, 2014
    Date of Event
    January 23, 2014
    Report Date
    March 18, 2014
    Manufacturer
    NA
    Product Code
    BYE
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER ATTACHED OPERATING INSTRUCTIONS LABEL PN 75282 EXPLAINED HOW TO ATTACH THE CIRCUIT PURSUANT TO STANDARD OPERATING PROTOCOL UNDER "SUGGESTED USE, STEP 1". THERE IS A SECTION SPECIFICALLY FOR THE PEEP VALVE OPERATING INSTRUCTIONS AND CAUTIONS AND WARNING SUCH AS "ALL USERS OF THIS DEVICE SHOULD READ INSTRUCTIONS FOR USE OF THE CIRCUIT AND ASSOCIATED TRANSPORT EQUIPMENT..." AS A RESULT OF THIS COMPLAINT AND IS ORDER TO MAKE THE INSTRUCTION AND THE DEVICE MORE CLEAR TO OPERATE, IT WAS ADDED A LABEL TO THE PEEP VALVE WITH BIG ARROWS DEFINING WELL THE TUBING CONNECTION AND PT CONNECTION ARE, THIS WAY, EVEN THOUGH THE USER DOESN'T READ THE INSTRUCTION FOR USE, IT WILL BE VISIBLE AND EVIDENT HOW TO ATTACH THE CIRCUIT AND THE PROPER WAY TO HOOK UP THE CONNECTORS CORRECTLY.

    Description of Event or Problem · 1

    MRI CIRCUIT WAS INCORRECTLY CONNECTED TO PT RESULTING IN ARRYTHMIA AND DESATURATION OF PT. PT WAS THEN BAGGED WITH RESUSCITATION AND O2 LEVEL ROSE TO NORMAL. THIS IS HOW THE ORIGINAL COMPLAINT WAS REPORTED BY (B)(6) TO WESTMED. THIS MEDWATCH IS A RESPONSE OF A MAUDE EVENT REPORT NO. (B)(4) SUBMITTED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159750 NA MRI TRANSPORT CIRCUIT BYE NA 9317 08272013401

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization