BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLYGO MINI

    MDR report key: 21866911 · Received April 18, 2025

    Report

    Report Number
    2518422-2025-104471
    Event Type
    Death
    Date Received
    April 18, 2025
    Date of Event
    March 19, 2025
    Report Date
    March 11, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    UDI-DI
    00606959032392
    PMA / PMN Number
    K111885
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT PASSED AWAY, AND HIS WIFE REACHED OUT TO INQUIRE ABOUT HOW TO DISPOSE OF THE SIMPLYGO MINI DEVICE. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. NO MEDICAL INTERVENTION WAS REPORTED. MULTIPLE GOOD-FAITH EFFORTS HAVE BEEN COMPLETED TO OBTAIN ADDITIONAL INFORMATION ON (06/03/2025, 06/21/2025, 07/04/2025) WITHOUT CUSTOMER RESPONSE. A FINAL REPORT IS BEING SUBMITTED. IF NEW INFORMATION BECOMES AVAILABLE FOLLOWING THE COMPLETION OF THE DEVICE REPAIR THAT CHANGES THE OUTCOME OF THE INVESTIGATION AND ASSOCIATED MEDICAL DEVICE REPORTING A FOLLOW-UP/SUPPLEMENTAL REPORT WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    NO DEVICE SERIAL NUMBER WAS PROVIDED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT PASSED AWAY, AND HIS WIFE REACHED OUT TO INQUIRE ABOUT HOW TO DISPOSE OF THE SIMPLYGO MINI DEVICE. THERE WAS NO ALLEGATION THAT THE DEVICE CONTRIBUTED TO THE DEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE DETAILS OF THE REPORTED DEATH. NO MEDICAL INTERVENTION WAS REPORTED. THE MANUFACTURER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION CONCERNING THIS EVENT AND THE COMPLAINT IS STILL UNDER INVESTIGATION. A FINAL REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1775358 SIMPLYGO MINI GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS, INC. 1113601 00606959032392

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death