BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLYGO

    MDR report key: 17780754 · Received September 20, 2023

    Report

    Report Number
    2518422-2023-23807
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    June 20, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    UDI-DI
    00606959005723
    PMA / PMN Number
    K111885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION RELATED TO A SIMPLYGO OXYGEN CONCENTRATOR. THE USER ALLEGES THE DC POWER SUPPLY IS FAULTY AND OUT OF WARRANTY. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. THE SERVICE CENTER REPORTS HIGH PRESSURE, CONTAMINATION, AND ALARMING/RED LIGHT. THERE IS NO ALLEGATION OF PATIENT HARM OR SERIOUS INJURY. NO MEDICAL INTERVENTION REPORTED. CORRECTION: DEVICE WAS EVALUATED BY A PHILIPS FIELD SERVICE ENGINEER. CORRECTED CODING IN EVALUATION METHOD CODE GRID AND DEVICE EVALUATED BY MFG.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION RELATED TO A SIMPLYGO OXYGEN CONCENTRATOR. THE USER ALLEGES THE DC POWER SUPPLY IS FAULTY AND OUT OF WARRANTY. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER. THE SERVICE CENTER REPORTS HIGH PRESSURE, CONTAMINATION, AND ALARMING/RED LIGHT. THERE IS NO ALLEGATION OF PATIENT HARM OR SERIOUS INJURY. NO MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83477 SIMPLYGO GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS, INC. 1068987 00606959005723

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown