BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JM103 TRANSCUTANEOUS BILIMETER

    MDR report key: 4148885 · Received October 1, 2014

    Report

    Report Number
    MW5038489
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 17, 2014
    Report Date
    October 1, 2014
    Manufacturer
    DRAEGER MEDICAL INC
    Product Code
    MQM
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014, MOM DELIVERED A NORMAL ((B)(6)) NEWBORN PRETERM AT (B)(6) GESTATION. ON (B)(6) 2014, NURSE WAS PERFORMING ROUTINE ORDER FOR A 24 HOUR (TCB) TRANSCUTANEOUS BILIRUBIN USING THE TRANSCUTANEOUS BILIRUBINOMETER (JAUNDICE METER) ON NEWBORN (B)(6) AGE. THE INITIAL READING ON THE JAUNDICE METER SCREEN WAS (- - -) LINES ACROSS THE SCREEN. THE NURSE THEN ATTEMPTED TO RECALIBRATE AND TRIED SEVERAL TIMES ON NEWBORN TO OBTAIN A NUMERICAL READING AND WAS UNSUCCESSFUL. NURSE DID ATTEMPT TO PERFORM TCB ON HERSELF AND WAS ABLE TO GET A NUMERICAL READING AND THEREFORE THOUGHT THERE WAS A PROBLEM WITH THE METER. NURSE THEN OBTAINED A SERUM BILIRUBIN AND LEVEL WAS 25.1 MG/DL. BABY REQUIRED EMERGENCY EXCHANGE TRANSFUSION AND TRANSFER TO NICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610449 JM103 TRANSCUTANEOUS BILIMETER JAUNDICE METER JM-103 MQM DRAEGER MEDICAL INC JM 103

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Life Threatening