BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10382894 · Received August 7, 2020

    Report

    Report Number
    3005934741-2020-00002
    Event Type
    Injury
    Date Received
    August 7, 2020
    Date of Event
    May 2, 2020
    Report Date
    July 9, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    FMZ
    UDI-DI
    10885403260759
    PMA / PMN Number
    K101778
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THREE PROBES WERE RETURNED WHICH ARE WORKING PROPERLY IN TERMS OF READING TEMPERATURE. HOWEVER, NO INSULATION RESISTANCE OR HIPOT TESTING PERFORMED DUE PRESENCE OF BREAKS IN THE CABLE JACKETS EXPOSING THE SHIELD WIRES. HEAT SHRINK WAS APPLIED ON ONE OF THE PROBES (NOT AS THE ORIGINAL CONDITION) IN ORDER TO KEEP USING IT AFTER THE CABLE JACKET HAD BEEN BREACHED. ALSO, PHOTO INCLUDED IN PACKAGE SHOWS BURN MAY HAVE BEEN CAUSED BY THE TIP OF THE PROBE (NOT THE INCUBATOR). BASED ON THE FINDINGS, IT WAS DETERMINED THAT THE REPORTED FAILURE IS NOT RELATED TO THE MANUFACTURING PROCESS BUT PERHAPS TO A USER ERROR BASED ON THE IFU (INSTRUCTIONS FOR USE) SUPPLIED TO EACH PROBE TO NOT TRY TO USE OR REPAIR A DAMAGED UNIT.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE 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 CUSTOMER REPORTED THAT A PATIENT SUFFERED A BURN INJURY INVOLVING THE AIRLIFE INFANT SKIN TEMPERATURE PROBE, AND MEDICAL INTERVENTION WAS REQUIRED TO TREAT THE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844242 AIRLIFE INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE, PANDA) INCUBATOR, NEONATAL FMZ VYAIRE MEDICAL AIRLIFE¿ INFANT SKIN TEMPERATURE PROBE, REUSABLE (GIRAFFE¿, PANDA¿) THM171105 10885403260759

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention