BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SERVO-N

    MDR report key: 8635718 · Received May 23, 2019

    Report

    Report Number
    8010042-2019-00336
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 23, 2019
    Manufacturer
    MAQUET CRITICAL CARE AB
    Product Code
    CBK
    PMA / PMN Number
    K180098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A FACILITY MEDWATCH REPORT MW5086054 WAS RECEIVED STATING THAT "FIO2 ON THE SERVO-N, DROPS BY 10% ON MICRO BABIES." ON THE REPORT THE EVENT REPORT TYPE WAS CHECKED AS SERIOUS INJURY AND THE EVENT OUTCOME AS LIFE THREATENING, DISABILITY/PERMANENT DAMAGE, REQUIRED INTERVENTION. THIS REPORT IS THEREFORE REPORTED AS AN ADVERSE EVENT SOLELY BASED ON THIS INFORMATION. THERE IS NO COMPLAINT IN OUR COMPLAINT DATA BASE TO CONFIRM THE REPORTED FIO2 DROPS BY 10 % ON MICRO BABIES. APART FROM THE RECEIVED PROBLEM DESCRIPTION STATED IN THE MEDWATCH REPORT, WE HAVE NOT RECEIVED ANY INFORMATION SUCH AS DEVICE SERIAL NUMBER, DEVICE LOGS, DEFECTIVE/REPLACED PARTS, VENTILATOR SETTINGS OR HOSPITAL CONTACT INFORMATION. NO INFORMATION REGARDING MEDICAL INTERVENTION HAS BEEN RECEIVED. THEREFORE NO INVESTIGATION HAS BEEN POSSIBLE. WE ARE THEREFORE UNABLE TO PROVIDE, DETERMINE OR CONFIRM THE TRUE CAUSE REPORTED ISSUE. FURTHERMORE, SHOULD ANY RELEVANT INFORMATION, THIS COMPLAINT WILL BE REOPENED AND INVESTIGATED FURTHER. GETINGE USA SALES, LLC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF MAQUET CRITICAL CARE AB (MANUFACTURER). REF. EXEMPTION #: E2018003. GETINGE USA SALES, LLC, 45 BARBOUR POND DRIVE, WAYNE, NJ 07470. CONTACT PERSON: (B)(4). H3 OTHER TEXT: 4119.

    Description of Event or Problem · 0

    A MEDWATCH REPORT WITH REFERENCE # MW5086054 WAS RECEIVED STATING THAT: "FIO2 ON THE SERVO-N, DROPS BY 10% ON MICRO BABIES. IF ONE IS NOT AWARE IT CAN AFFECT THE BABY'S OVERALL HEALTH. SPOKE TO MFR REP AND THEY HAVE NO CLUE WHY THIS IS HAPPENING. WE TRY TO REPRODUCE THE DECREASE IN FIO2 ON ATTEST LUNG THINKING IT WAS JUST THE BABY. BUT WE REPRODUCED THE EFFECT ON A BABY TEST LUNG. I REACHED OUT TO MFR AND THEY DO NOT HAVE A CLUE AS TO WHY THIS IS HAPPENING. THE FDA SHOULD INVESTIGATE THIS PT SAFETY ISSUE A BIT CLOSER." THE EVENT REPORT TYPE IN THE RECEIVED MEDWATCH REPORT # MW5086054 IS SET TO SERIOUS INJURY. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430672 SERVO-N VENTILATOR, CONTINUOUS, FACILITY USE CBK MAQUET CRITICAL CARE AB

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening