BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLYGO MINI

    MDR report key: 17971980 · Received October 20, 2023

    Report

    Report Number
    2518422-2023-26406
    Event Type
    Malfunction
    Date Received
    October 20, 2023
    Date of Event
    October 2, 2023
    Report Date
    August 2, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K111885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE SERVICED BY THIRD PARTY SERVICE CENTER

    Additional Manufacturer Narrative · 0

    IN BOX D "PRODUCT UDI (RFB)" SECTION HAS BEEN CORRECTED. THE UDI IN SECTION WAS PREVIOUSLY REPORTED IN THE INCORRECT FORMAT. THE UDI INFORMATION HAS BEEN UPDATED TO THE CORRECT FORMAT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING ISSUES WITH A SIMPLYGO MINI,EXTENDED BATTERY. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY. THE MANUFACTURER RECEIVED THE DEVICE FOR INVESTIGATION. THE MANUFACTURER CONFIRMED THE COMPLAINT AND REPLACED 1131554B, 1131550B, 1140694B, 1140695, 1124287B, AND 1124257B. FOUND SIEVE BEDS WITH LOW O2, O2 SIDE CHECK VALVES MALFUNCTIONING, AIRSIDE MANIFOLD CHIRPING, PILOT VALVES CAUSING CYCLING ERROR, MAIN PCA HAS LOW FLOW, COMPRESSOR LEAD WIRE DAMAGED. UPDATED SIMPLYGO MINI SOFTWARE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242401 SIMPLYGO MINI GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS, INC. 1113602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown