BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿)

    MDR report key: 14627341 · Received June 7, 2022

    Report

    Report Number
    3005934741-2022-00002
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    May 5, 2022
    Report Date
    May 11, 2022
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    FMZ
    UDI-DI
    10190752179622
    PMA / PMN Number
    K101778
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). THE DEVICE WAS NOT YET RETURNED, THEREFORE A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AND CORRECTIVE OR PREVENTIVE ACTION IS NOT INDICATED AT THIS TIME. 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 · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿) WARMER WAS OVERHEATING. THE CUSTOMER CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. THE EVENT OCCURRED DURING PRE-USE CHECK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184689 AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿) INCUBATOR, NEONATAL FMZ VYAIRE MEDICAL AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿) UNKNOWN 10190752179622

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown