BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLYGO

    MDR report key: 19329034 · Received May 16, 2024

    Report

    Report Number
    2518422-2024-28643
    Event Type
    Malfunction
    Date Received
    May 16, 2024
    Date of Event
    April 3, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CZW
    UDI-DI
    00606959020801
    PMA / PMN Number
    K111885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 0

    A SIMPLYGO DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER ALLEGING THE DEVICE WOULD TURN OFF. DURING EVALUATION OF THE DEVICE, THE DEVICE WAS FOUND TO HAVE THERMAL DAMAGE TO THE PCA (PRINTED CIRCUIT ASSEMBLY). THE PCA WAS BURNED AND IN NEED OF REPLACEMENT. THE DEVICE WAS ALSO FOUND TO HAVE LOW OXYGEN, AND THE SIEVES WERE DEFECTIVE AND NEEDED REPLACEMENT. THE TUBING KIT WAS CONTAMINATED. THE COMPRESSOR WAS IN NEED OF REPLACEMENT, AND THE INLET FILTER WAS REPLACED DUE TO PREVENTATIVE MAINTENANCE. THE DEVICE WAS REPAIRED AND PASSED A PERFORMANCE TEST. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548675 SIMPLYGO GENERATOR, OXYGEN, PORTABLE CZW RESPIRONICS, INC. 1069058 00606959020801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown