BEUDAMED
    FDA Adverse Event Summary report: N

    RESUS BAG AD MANUAL VARIABLE 6/CS

    MDR report key: 3013602 · Received March 20, 2013

    Report

    Report Number
    8030673-2013-00034
    Date Received
    March 20, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 7, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BTM
    PMA / PMN Number
    K924610
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: THE SAMPLE REGARDING THIS REPORT WAS NOT AVAILABLE FOR EVALUATION. A PRODUCTION RECORD REVIEW WAS NOT POSSIBLE TO SEARCH FOR ANY EXTRAORDINARY EVENTS AS THE LOT NUMBER FOR THE PRODUCT WAS NOT AVAILABLE. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED WITH THIS PRODUCT. THE INSTRUCTIONS FOR USE FOR THE 2K8017 ADULT MANUAL RESUSCITATOR CONTAINS A DIAGRAM WHICH INSTRUCTS ON THE PROPER ATTACHMENT OF THE MASK TO THE PRODUCT, ¿TO ATTACH RESUSCITATION BAG TO MASK, PRESS CONNECTOR ¿C¿ INTO OUTLET ¿D¿ OF THE MASK¿. IN ADDITION, THE EXHALATION PORT OF THIS PRODUCT IS CLEARLY LABELED WITH THE FOLLOWING STATEMENT ¿DO NOT OCCLUDE EXHALATION PORT¿. THE MASK OF THIS PRODUCT CONTAINS A 22 MM FIT, WHILE THE EXHALATION PORT CONTAINS A 33 MM FITTING, MAKING A DIFFICULT FIT UNLESS FORCED. AT THIS TIME, THERE IS NO CORRECTIVE ACTION IN PLACE AS IT APPEARS THAT THE PRODUCT WAS MISUSED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. UPON COMPLETION OF CAREFUSION'S INVESTIGATION, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO CAREFUSION: PHYSICIAN CALLED TODAY FROM THE MEDICAL DIRECTOR OF CRITICAL CARE MEDICINE RESPOND TEAM EXPLAINING TO ME THAT ONE OF HIS BOARD CERTIFIED PHYSICIAN ALMOST KILLED A PATIENT BY PUTTING THE MASK INTO THE EXHALATION PORT AND TRYING TO RESUSCITATE A PATIENT. I EXPLAINED TO HIM THAT THIS IS A 30MM FITTING AND IT WON'T FIT. ACCORDING TO THIS PHYSICIAN, HE WAS FORCING IT IN TO MAKE IT FIT. PATIENT DIDN'T EXPIRE BUT HAD A PACO2 OF 95MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115652 RESUS BAG AD MANUAL VARIABLE 6/CS VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR) BTM CAREFUSION 2K8017

    Patients

    Seq Age Sex Outcome Treatment
    1 Other