BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X

    MDR report key: 12081210 · Received June 28, 2021

    Report

    Report Number
    8030673-2021-00177
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 1, 2021
    Product Code
    CAI
    UDI-DI
    10190752147379
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE OPENED SAMPLE PART NUMBER R6860K WAS RECEIVED FOR THE INVESTIGATION. BASED ON THE INVESTIGATION AND PER THE PHYSICAL SAMPLE AND PICTURES PROVIDED BY THE CUSTOMER, WE COULD OBSERVE THAT THE BLUE VALVE IS LOOSE INSIDE THE CUSHION, SO THE DEFECT WAS CONFIRMED. WE DETERMINED THAT THE MATERIAL COULD BE RELATED SINCE THE PART NUMBER R6860K IS NOT MANUFACTURED IN VYAIRE MEXICALI AND WE DO NOT MANIPULATE THE BLUE VALVE. IN ADDITION, THE PFMEA 76A REFERS TO THE PFMEA 83A FOR RAW MATERIAL, AND WE HAVE THE CONTROLS FOR THIS KIND OF ISSUE. AS A CORRECTIVE AND PREVENTIVE ACTION, SCAR MX-2021-030 WAS INITIATED FOR THE EXTERNAL SUPPLIER. ALSO, PERSONNEL WAS NOTIFIED ABOUT THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE PRODUCT IS AVAILABLE TO BE RETURNED FOR INVESTIGATION. PICTURES ARE ALSO ATTACHED. THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE 6861- VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X -LARGE ADULT FACE MASK, DEFLATED WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRMED THAT THERE WAS NO HARM AND THERE WAS NO INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    977043 VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI VITAL SIGNS® EXTRA LARGE FACE MASK WITH ADJUSTABLE AIR CUSHION SIZE 6X -LARGE AD UNKNOWN 10190752147379

    Patients

    Seq Age Sex Outcome Treatment
    1