BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESUS BAG

    MDR report key: 6366180 · Received February 28, 2017

    Report

    Report Number
    2246980-2017-00011
    Event Type
    Death
    Date Received
    February 28, 2017
    Date of Event
    January 5, 2017
    Report Date
    February 1, 2017
    Manufacturer
    VENTLAB LLC.
    Product Code
    BTM
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE WAS NOT RETURNED FOR EVALUATION HOWEVER EVERY MASK THAT SUNMED MANUFACTURERS IS CHECKED FOR INFLATION BEFORE IT IS PLACED INTO A RESUSCITATION KIT. IF THE INFLATION OF A MASK IS DETERMINED TO BE LOW, THE PRODUCTION OPERATORS WILL RE-INFLATE IT PER THE APPROVED WORK INSTRUCTIONS. IF A MASK IS DETERMINED TO BE FLAT IT WILL BE SCRAPPED. THE CUSTOMER DID NOT COMPLAIN ABOUT THE MASKS BEING DEFLATED. THE COMPLAINT STATED THAT THE MASKS DID NOT PROVIDE A GOOD SEAL AROUND THE PATIENT'S FACE. THE MASK IN QUESTION IS AN ADULT MASK THAT IS RELATIVELY LARGE IN SIZE. THIS COMPLAINT ORIGINATED IN A NURSING HOME SO IT FEASIBLE THAT THE MASK WAS NOT THE CORRECT SIZE FOR THE PATIENT. THIS MIGHT EXPLAIN WHY THE CUSTOMER HAD THE SAME PROBLEM WITH TWO MASKS THAT WERE USED BACK-TO BACK. OVERALL THERE IS NOT ENOUGH INFORMATION TO STATE THAT THE DEVICES DID NOT MEET A SPECIFIED REQUIREMENT OR MALFUNCTIONED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGES "THE MASK ON THE RESUS BAG DID NOT PROVIDE A PROPER SEAL AROUND THE PATIENT'S FACE." THE CUSTOMER ALSO STATES THAT A SECOND MASK WAS RETRIEVED AND THE SAME ISSUE OCCURRED. THE RESIDENT WAS SUBSEQUENTLY TRANSPORTED TO THE EMERGENCY ROOM AND DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149469 RESUS BAG BTM VENTLAB LLC. CPRM1116 306996

    Patients

    Seq Age Sex Outcome Treatment
    1