BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIMPLYGO MINI

    MDR report key: 17921817 · Received October 12, 2023

    Report

    Report Number
    2518422-2023-26439
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 29, 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
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE EVALUATED BY THIRD PARTY.

    Additional Manufacturer Narrative · 0

    SECTION B5 - DESCRIBE AN EVENT OR PROBLEM THAT SHOULD BE REPORTED AS: THE MANUFACTURER RECEIVED INFORMATION ALLEGING ISSUES WITH A SIMPLYGO MINI,EXTENDED BATTERY. THERE WAS NO REPORT OF SERIOUS HARM OR INJURY. THE DEVICE WAS SERVICED BY A PHILIPS FIELD SERVICE ENGINEER AND INSPECTED1131554B;1140694B;1131550B;1132383, SIEVE BEDS LOW O2, MANIFOLD ASSEMBLY LEAKS, MANIFOLD ASSEMBLY LEAKS, DAMAGED POWER CONNECTOR. SECTION H6, EVALUATION METHOD CODE GRID HAS BEEN CORRECTED IN THIS REPORT. SECTION H7-REMEDIAL ACTION WOULD NOT BE APPLICABLE, WHICH HAS BEEN CORRECTED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    D4 AND G1 SECTION HAS BEEN CORRECTED AND UPDATED. THE UDI IN SECTION D4 WAS PREVIOUSLY REPORTED IN THE INCORRECT FORMAT, NOW THE UDI INFORMATION HAS BEEN UPDATED TO THE CORRECT FORMAT.

    Description of Event or Problem · 0

    THE DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER FOR SERVICE. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE WAS VISUALLY INSPECTED AND DURING THE EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER IT WAS FOUND THAT THE SIEVE BEDS HAD LOW O2, MANIFOLD ASSEMBLY LEAKS, AND A DAMAGED POWER CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505563 SIMPLYGO MINI GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS, INC. 1134722

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown