BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE-STAT

    MDR report key: 17435806 · Received August 1, 2023

    Report

    Report Number
    1821850-2023-00001
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 5, 2023
    Report Date
    August 1, 2023
    Manufacturer
    MICHIGAN INSTRUMENTS, LLC
    Product Code
    DRM
    PMA / PMN Number
    K073079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, CUSTOMER COMPLAINT OF VENTILATION VOLUME NOT FUNCTIONING WAS CONFIRMED. VENTILATION KNOB WAS FOUND TO BE ROTATING AROUND THE VENTILATION NEEDLE STEM. THIS WAS DUE TO SET SCREWS BEING ROUNDED OFF ON THE VENTILATION NEEDLE STEM. REPLACED SET SCREWS IN VENTILATION KNOB. TESTED AND ACCEPTED TO FACTORY SPECIFICATIONS AND RETURNED TO CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTILATION KNOB WAS NON-FUNCTIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344631 LIFE-STAT EXTERNAL CARDIAC COMPRESSOR DRM MICHIGAN INSTRUMENTS, LLC 1008 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown