BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVERFLO DOM NON- OPI 120V US/CAN

    MDR report key: 18188677 · Received November 21, 2023

    Report

    Report Number
    2518422-2023-31315
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    November 2, 2023
    Report Date
    August 2, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CAW
    PMA / PMN Number
    K061261
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON AN EVERFLO DOM NON- OPI 120V US/CAN THAT WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR SERVICE. THE PATIENT ALLEGES THE COOLING FAN SEIZED UP, THE COMPRESSOR OVERHEATED, THE BEARINGS WERE VERY LOUD, AND THE SIEVE BED WAS LEAKING. THERE WAS NO HARM OR INJURY REPORTED. DURING THE DEVICE'S EVALUATION AT THE MANUFACTURER, SIEVES AND CANISTERS WERE RETURNED FROM FASC/SERVICE; FAULTS WERE IDENTIFIED DURING THE INSTALLATION PROCESS, AND THEY WERE RETURNED FOR CREDIT OR REPLACEMENT. THE MATERIALS WERE SCRAPPED, RECYCLED, OR RELACED. UDI RELATED DATA QUALITY UPDATE. THE UDI IN SECTION D4 WAS PREVIOUSLY REPORTED IN THE INCORRECT FORMAT. THE UDI INFORMATION HAS BEEN UPDATED TO THE CORRECT FORMAT.

    Description of Event or Problem · 0

    AN EVERFLO DOM NON- OPI 120V US/CAN WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR SERVICE. THE PATIENT ALLEGES THE COOLING FAN SEIZED UP, THE COMPRESSOR OVERHEATED, THE BEARINGS WERE VERY LOUD, AND THE SIEVE BED WAS LEAKING. THERE WAS NO HARM OR INJURY REPORTED. DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER, SIEVES CANISTERS RETURNED FROM FASC/SERVICE; FAULTS IDENTIFIED DURING THE INSTALLATION PROCESS; RETURNED FOR CREDIT/REPLACEMENT. THE MATERIALS WERE SCRAPPED/RECYCLED/RELACED. THE FAILURE REPORTED IN THE COMPLAINT HAS BEEN EVALUATED IN THE PQA-2103087. NO FURTHER INVESTIGATION OF THIS FAILURE IS REQUIRED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744177 EVERFLO DOM NON- OPI 120V US/CAN GENERATOR, OXYGEN, PORTABLE CAW RESPIRONICS, INC. 1020000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown