BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REP DREAMSTATION AUTO CPAP

    MDR report key: 16495818 · Received March 7, 2023

    Report

    Report Number
    2518422-2023-06362
    Event Type
    Malfunction
    Date Received
    March 7, 2023
    Date of Event
    February 14, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K 131982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON (B)(4) MDR 2518422-2023-06362-1 THE BECOME AWARE DATE TO BE 24-JUN-2022. THIS IS INCORRECT. THE CORRECT BECOME AWARE DATE IS 24-JUN-2023. THIS DATE IS CORRECTED IN THE GENERAL INFORMATION TAB IN THE BECOME AWARE DATE FIELD.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THAT A USER OF A REP DREAMSTATION AUTO CPAP DEVICE ALLEGEDLY HAD A THERMAL EVENT WHILE NOT IN USE BUT PLUGGED INTO AN AC OUTLET. USER STATED HE HEARD A NOISE, TURNED AND SAW HIS DEVICE ON FIRE. USER GRABBED A FIRE EXTINGUISHER AND PUT OUT THE FLAME. THERE WAS ALLEGED VISIBLE DAMAGE TO THE POWER CORD/POWER SUPPLY. A NEW POWER CORD AND SUPPLY WERE PROVIDED BUT THE DEVICE WOULD NOT TURN ON. THERE WAS NO HARM OR INJURY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THREE ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED. H3 OTHER TEXT : NO DEVICE RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THE MANUFACTURER BECAME AWARE THAT A USER OF A REP DREAMSTATION AUTO CPAP DEVICE ALLEGEDLY HAD A THERMAL EVENT WHILE NOT IN USE BUT PLUGGED INTO AN AC OUTLET. USER STATED HE HEARD A NOISE, TURNED AND SAW HIS DEVICE ON FIRE. USER GRABBED A FIRE EXTINGUISHER AND PUT OUT THE FLAME. THERE WAS ALLEGED VISIBLE DAMAGE TO THE POWER CORD/POWER SUPPLY. A NEW POWER CORD AND SUPPLY WERE PROVIDED BUT THE DEVICE WOULD NOT TURN ON. THERE WAS NO HARM OR INJURY REPORTED. NO DEVICE HAS BEEN RETURNED YET FOR INVESTIGATION. THE MANUFACTURER IS SUBMITTING AN INITIAL REPORT AT THIS TIME. A FOLLOW-UP FINAL WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716446 REP DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX500S11F

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male