BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 13623614 · Received February 28, 2022

    Report

    Report Number
    2518422-2022-06346
    Event Type
    Malfunction
    Date Received
    February 28, 2022
    Date of Event
    September 18, 2017
    Report Date
    May 22, 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
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS BEING SUBMITTED AS PART OF A BATCH SUBMISSION OF COMPLAINTS THAT WERE REASSESSED AS REPORTABLE FOAM DEGRADATION COMPLAINTS; DISCOVERED AS PART OF A RETROSPECTIVE REMEDIATION REVIEW.

    Additional Manufacturer Narrative · 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING AN VISUALIZATION OF PARTICLES RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED. THERE WAS NO MENTION OF VISUAL FINDINGS TO THE EXTERNAL PART OF THE DEVICE. THE INTERNAL ASPECT OF THE DEVICE WAS INSPECTED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THERE WERE TWENTY TWO ERRORS FOUND. THE MANUFACTURER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO PROBLEM FOUND. SECTION D8, D9 AND H6 HAS BEEN UPDATED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THIS DEVICE ON MDR 2518422-2022-06346-1. PLEASE DISREGARD MDR 2518422-2022-06346-1 AS IT WAS FILED IN ERROR.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE REPORTER ALLEGES SEEING MOLD INSIDE THE UNIT AND FILTER IS BLACK. THE DEVICE WAS RETURNED AND THERE WAS NO MOLD BUT BLACK CONTAMINANTS IN FILTER OBSERVED DURING DEVICE EVALUATION. THERE WAS NO ALLEGATION OF HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1567846 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS,INC DSX500H11

    Patients

    Seq Age Sex Outcome Treatment
    1 Female