BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 16264735 · Received January 30, 2023

    Report

    Report Number
    2518422-2023-03181
    Event Type
    Malfunction
    Date Received
    January 30, 2023
    Date of Event
    January 26, 2023
    Report Date
    April 29, 2023
    Manufacturer
    RESPIRONICS, INC
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO SOUND ABATEMENT FOAM. UPON FURTHER REVIEW, THIS DEVICEWAS A REPAIRED DEVICE AND DID NOT CONTAIN SOUND ABATEMENT FOAM THAT WOULD BE LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUSINJURY AND IS NOT IN SCOPE OF RES (B)(4). THEREFORE, THERE IS NO ALLEGATION OF A REPORTABLE EVENT ASSOCIATED WITH THE DEVICE AT THISTIME.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED MDR 2518422-2023-03181-1 INCORRECTLY SUBMITTED. PLEASE DISREGARD MDR 2518422-2023-03181-1 AS IT WAS FILED IN ERROR.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM.THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER FOR INVESTIGATION. EXTERNAL EXAMINATION OF THE UNIT FOUND SCRATCHES ON UPPER ENCLOSURE. INTERNAL EXAMINATION FOUND VISIBLE FOAM PARTICLES INSIDE THE BLOWER KIT. NO OTHER CONTAMINATION WAS OBSERVED IN THE DEVICE. THE DEVICE WAS POWERED ON AND IS FUNCTIONAL. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE THIRD PARTY SERVICE CENTER AND 0 ERROR WAS LOGGED. THE MANUFACTURER CONFIRMED THE THIRD PARTY SERVICE CENTER FOUND EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE DEVICE WAS RETURNED AND MANUFACTURER FOUND EVIDENCES OF FOAM DEGRADATION DURING DEVICE EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15058 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC DSX500T11W

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown