BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 17487989 · Received August 9, 2023

    Report

    Report Number
    2518422-2023-19090
    Event Type
    Malfunction
    Date Received
    August 9, 2023
    Date of Event
    January 6, 2022
    Report Date
    November 27, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    PMA / PMN Number
    K090539
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO THE MANUFACTURER¿S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE DEVICE WAS VISUALLY INSPECTED BY THE MANUFACTURER DUST CONTAMINANT INSIDE THE AIR INLET OF THE BLOWER BOX. AN UNKNOWN CONTAMINANT WAS OBSERVED ON THE TOP ENCLOSURE, REAR PANEL, BOTTOM ENCLOSURE, BLOWER, BLOWER SEAL, AND BLOWER BOX. EVIDENCE OF LIQUID INGRESS WAS OBSERVED TO THE BLOWER AND BLOWER BOX. A KERATIN-LIKE SUBSTANCE WAS OBSERVED ON THE BLOWER BOX OUTLET. ER-2243857(V01) ADDRESSES THE ISSUE OF KERATIN. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED.

    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. PATIENT ALLEGED HAVING HEADACHE. THE DEVICE WAS RETURNED BUT NOT YET EVALUATED. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1689210 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown