BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIGITAL MONITORING SYSTEM

    MDR report key: 14140827 · Received April 19, 2022

    Report

    Report Number
    14140827
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    October 29, 2021
    Report Date
    April 12, 2022
    Manufacturer
    SENTEC AG
    Product Code
    KLK
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT HAD AN URGENT C-SECTION. APPEARANCE, PULSE, GRIMACE, ACTIVITY, AND RESPIRATION (APGARS) SCORE NOTED AS 3, 6, 6. BABY WAS CYANOTIC AT DELIVERY. PATIENT INTUBATED EPI X 1 GIVEN VIA ENDOTRACHEAL TUBE (ETT) 5 ML NS BOLUS WAS ALSO ADMINISTERED. THE SENTEC TCOM DEVICE WAS APPLIED TO BABY ONE DAY AND WOUND CARE DOCUMENTED A SUSTAINED A RIGHT OUTER ABDOMEN WOUND. BABY TREATED WITH BACITRACIN AND MEPITEL. AFTER 12 DAYS THE BABY WAS TRANSFERRED TO ANOTHER HOSPITAL FOR HIGHER LEVEL OF CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819672 DIGITAL MONITORING SYSTEM TRANSCUTANEOUS BLOOD GAS MONITORING SYSTEM KLK SENTEC AG

    Patients

    Seq Age Sex Outcome Treatment
    1 8 DA Male Required Intervention| O