BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLYGO MINI,STND BATTERY,IKK

    MDR report key: 21982161 · Received May 7, 2025

    Report

    Report Number
    2518422-2025-105284
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 29, 2025
    Report Date
    August 15, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    UDI-DI
    00606959033825
    PMA / PMN Number
    K111885
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS PREVIOUSLY CONTACTED REGARDING A SIMPLYGO MINI STAND BATTERY IKK DEVICE DUE TO REPORTS OF IT SMOKING. THE DEVICE WAS RECEIVED AT THE THIRD-PARTY SERVICE CENTER FOR INSPECTION, AND THE EVALUATION NOTES INDICATE THAT THE CUSTOMER'S COMPLAINT REGARDING A "SMOKING DEVICE/PREPARATION" COULD NOT BE REPRODUCED. HOWEVER, THE ASSESSMENT REVEALED SEVERAL ISSUES: THE SIEVES WERE CLOGGED, AND THERE WERE AIR LEAKS ON BOTH THE AIR AND O2 SIDES OF THE DEVICE. ADDITIONALLY, THE INLET FILTER NEEDED TO BE REPLACED FOR PREVENTIVE MAINTENANCE, AND THE RP-SIMPLYGO MINI ALARM/TILT SENSOR WAS MISSING. DESPITE THE INITIAL COMPLAINT NOT BEING REPLICATED, THE DEVICE WAS REPAIRED. FOLLOWING THESE ACTIONS, THE DEVICE HAS BEEN SERVICED, INSPECTED, AND TESTED AND HAS MET ALL ACCEPTANCE CRITERIA IN ACCORDANCE WITH THE APPLICABLE CUSTOMER REQUIREMENTS AS DEFINED IN THE CONTRACTUAL AGREEMENT WITH THE THIRD-PARTY SERVICE CENTER.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS PREVIOUSLY NOTIFIED ABOUT A COMPLAINT REGARDING THE DEVICE SMOKING. A FIELD SERVICE TECHNICIAN THEN INSPECTED THE DEVICE, REPLACED THE NECESSARY COMPONENTS IDENTIFIED DURING THE EVALUATION, AND RESTORED THE DEVICE TO FULL OPERATIONAL FUNCTIONALITY. ALTHOUGH THE TECHNICIAN WAS UNABLE TO REPLICATE THE REPORTED ISSUE AND NO RELEVANT REPORTABLE INFORMATION WAS RECEIVED, A FOLLOW-UP REPORT WAS MISTAKENLY FILED WITHOUT THE APPROPRIATE CODING. THIS HAS NOW BEEN CORRECTED IN THIS REPORT, AND THE CORRECT CODING HAS BEEN ADDED.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED ABOUT A SIMPLYGO MINI STAND BATTERY IKK DEVICE DUE TO REPORTS OF IT SMOKING. THE SERVICE CENTER HAS RECEIVED THE DEVICE FOR EVALUATION. IMPORTANTLY, THERE ARE NO CLAIMS OF PATIENT HARM OR SERIOUS INJURY, AND NO MEDICAL INTERVENTION HAS BEEN SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS STILL IN PROGRESS. IF ANY ADDITIONAL RELEVANT INFORMATION COMES IN, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794968 SIMPLYGO MINI,STND BATTERY,IKK GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS, INC. 1113607 00606959033825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown