BEUDAMED
    FDA Adverse Event Other Summary report: N

    PRACTI-VALVE TRAINING VALVES, WNL PRACTI-VALVE

    MDR report key: 6166251 · Received December 8, 2016

    Report

    Report Number
    MW5066628
    Event Type
    Other
    Date Received
    December 8, 2016
    Date of Event
    August 15, 2016
    Report Date
    November 25, 2016
    Manufacturer
    WORK 'N LEISURE
    Product Code
    BYG
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I WAS USING THIS PRODUCT IN A CPR TRAINING CLASS. THE VALVES DETACHED FOR BOTH STUDENTS IN THE CLASS. I GAVE THEM NEW ONES, AND THOSE VALVES DETACHED ALSO. INJURY INFORMATION: INCIDENT, NO INJURY. PRODUCT DESCRIPTION: THE PRACTI-VALVE TRAINING VALVES ARE USED TO PRACTICE MOUTH TO MOUTH RESUSCITATION/CPR. THE TRAINEE CONNECTS THE BLUE PLASTIC AIR VALVE TO A PLASTIC MASK, PLACES IT OVER THE DUMMY'S MOUTH AND BLOWS THROUGH THE VALVE TO FILL THE DUMMY'S LUNGS WITH AIR. RETAILER: (B)(6). PURCHASE DATE: (B)(6) 2015. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. HAVE YOU CONTACTED THE MANUFACTURER: NO. DOCUMENT NUMBER: (B)(4), REPORT NUMBER: (B)(4).

    Description of Event or Problem · 2

    I WAS USING THIS PRODUCT IN A CPR TRAINING CLASS. THE VALVES DETACHED FOR BOTH STUDENTS IN THE CLASS. I GAVE THEM NEW ONES, AND THOSE VALVES DETACHED ALSO. INJURY INFORMATION: INCIDENT, NO INJURY. PRODUCT DESCRIPTION: THE PRACTI-VALVE TRAINING VALVES ARE USED TO PRACTICE MOUTH TO MOUTH RESUSCITATION/CPR. THE TRAINEE CONNECTS THE BLUE PLASTIC AIR VALVE TO A PLASTIC MASK, PLACES IT OVER THE DUMMY'S MOUTH AND BLOWS THROUGH THE VALVE TO FILL THE DUMMY'S LUNGS WITH AIR. RETAILER: (B)(6). PURCHASE DATE: (B)(6) 2015. THE PRODUCT WAS DAMAGED BEFORE THE INCIDENT: NO. THE PRODUCT WAS MODIFIED BEFORE THE INCIDENT: NO. HAVE YOU CONTACTED THE MANUFACTURER: NO. DOCUMENT NUMBER: (B)(4), REPORT NUMBER: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807263 PRACTI-VALVE TRAINING VALVES, WNL PRACTI-VALVE PRACTI-VALVE TRAINING VALVES, WNL PRACTI-VALVE BYG WORK 'N LEISURE PRACTI-VALVE CPR TRAINING VALVES
    807264 PRACTI-VALVE TRAINING VALVES, WNL PRACTI-VALVE PRACTI-VALVE TRAINING VALVES, WNL PRACTI-VALVE BYG WORK 'N LEISURE PRACTI-VALVE CPR TRAINING VALVES

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR
    2 30 YR