BEUDAMED
    FDA Adverse Event Death Summary report: N

    NELLCOR

    MDR report key: 5397127 · Received January 28, 2016

    Report

    Report Number
    2936999-2016-00071
    Event Type
    Death
    Date Received
    January 28, 2016
    Date of Event
    January 16, 2016
    Report Date
    January 7, 2016
    Manufacturer
    GALWAY (RP)-RX
    Product Code
    DQA
    PMA / PMN Number
    K123581
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED FAILURE OF 'UNIT DID NOT ALARM' WAS NOT VERIFIED. THE SERVICE HISTORY FOR THIS SERIAL NUMBER WAS INVESTIGATED FOR SIMILAR COMPLAINT MODE. NO SIMILAR COMPLAINT MODE WAS FOUND IN THE SERVICE HISTORY. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES AND COMPLAINT TRENDS ARE REVIEWED MONTHLY TO DETERMINE IF ADDITIONAL ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN/MEDTRONIC HAS REQUESTED RETURN OF THE DEVICE FOR INVESTIGATION.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE N600X DID NOT ALARM WHILE ON A (B)(6) INFANT. THE BABY HAD BOTH A PULSE OXIMETER AND AN APNEA MONITOR ON. AT 0615 WHEN THE NURSE WAS LAST IN THE ROOM, THE INFANT AND MOM APPEARED TO BE SLEEPING AND THE PULSE OXIMETER WAS REGISTERING 94%SPO2. THE CHARGE NURSE STATED SHE HEARD A WHINING SOUND COMING FROM THE APNEA MONITOR WHEN SHE WENT INTO THE ROOM FOR THE CODE AND SHE TURNED IT OFF AND STARTED THE CODE. THE INFANT DIED. THE INFANT WAS (B)(6) GESTATION AT BIRTH (B)(6). AT THE TIME OF THE EVENT THE INFANT WAS (B)(6). SUPPORT THE INFANT WAS ON AT THE TIME OF THE EVENT: IV FLUIDS, D5%1/4NS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54811 NELLCOR (D) N600X PULSE OXIMETER OXIMAX X1 DQA GALWAY (RP)-RX N600X

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO Death| R