BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS¿ HEAD POSITIONER

    MDR report key: 12529462 · Received September 24, 2021

    Report

    Report Number
    3013421741-2021-00001
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 24, 2021
    Report Date
    August 25, 2021
    Product Code
    CCX
    UDI-DI
    00749756999007
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONFIRMED THAT THE PRODUCT SAMPLE AND PHOTO ARE NOT AVAILABLE FOR ANALYSIS. HOWEVER, THE LOT NUMBER WAS PROVIDED TO CONDUCT A DEVICE HISTORY RECORD REVIEW. THE ISSUE OCCURRED WITH TWO PATIENTS. PLEASE REFER TO (B)(4) FOR THE OTHER PATIENT. ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE 8000 HDP VITAL SIGNS¿ HEAD POSITIONER SPLIT INTO TWO WHILE ON PATIENT USE, HOWEVER, IT WAS CONFIRMED THAT THERE WAS NO HARM ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428029 VITAL SIGNS¿ HEAD POSITIONER SUPPORT, PATIENT POSITION CCX VITAL SIGNS¿ HEAD POSITIONER 53748741 00749756999007

    Patients

    Seq Age Sex Outcome Treatment
    1