BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYAIRE MEDICAL INC

    MDR report key: 19294142 · Received May 10, 2024

    Report

    Report Number
    8030673-2024-01006
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    March 18, 2024
    Report Date
    May 10, 2024
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    OEV
    UDI-DI
    10190752114159
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 10 MAY 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE FDA MEDWATCH REPORT RECEIVED FROM UPMC WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THERE WILL NOT BE AN INVESTIGATION FOLLOW UP ON THE COMPLAINT SINCE THE CUSTOMER WILL NOT BE PURSUING ANY ACTION ON THIS MATTER.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 10 MAY 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. AIRLIFE HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE FDA MEDWATCH REPORT RECEIVED FROM UPMC WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    RECIEVED A MEDWATCH REPORT FROM FDA STATING THAT THERE WAS A PRODUCT MALFUNCTION WITH A DEVICE THAT WAS INCLUDED IN A PRODUCT RECALL.

    Description of Event or Problem · 0

    RECEIVED A MEDWATCH REPORT FROM FDA STATING THAT THERE WAS A PRODUCT MALFUNCTION WITH A DEVICE THAT WAS INCLUDED IN A PRODUCT RECALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529558 VYAIRE MEDICAL INC RESUSCITATION, ADLT W/MASK, 40" TBG, OEV VYAIRE MEDICAL 275224 0004173743 10190752114159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other